Trial Outcomes & Findings for Diabetes Prevention Program Feasibility Study of Breastfeeding (NCT NCT04021602)
NCT ID: NCT04021602
Last Updated: 2025-01-13
Results Overview
The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
At baseline and at delivery through 6 months postpartum
Results posted on
2025-01-13
Participant Flow
Participant milestones
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
12
|
|
Overall Study
COMPLETED
|
5
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
Baseline Characteristics
Diabetes Prevention Program Feasibility Study of Breastfeeding
Baseline characteristics by cohort
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=9 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=14 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=12 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
27.6 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Non-Hispanic White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Non-Hispanic Black
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Location
Rural
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Location
Urban
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Highest Level of Education Completed
Some high school
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Highest Level of Education Completed
Graduated from high school
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Highest Level of Education Completed
Some college or associate's degree
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Highest Level of Education Completed
Graduated with a bachelor's degree
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Highest Level of Education Completed
Advanced degree (e.g. Masters, PhD, MD, JD)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Gross yearly total household income before taxes during the last 12 months before current pregnancy
$9,999 or less
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Gross yearly total household income before taxes during the last 12 months before current pregnancy
$10,000 to $24,999
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Gross yearly total household income before taxes during the last 12 months before current pregnancy
$25,000 to $49,999
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Gross yearly total household income before taxes during the last 12 months before current pregnancy
$50,000 to $74,999
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Gross yearly total household income before taxes during the last 12 months before current pregnancy
$75,000 or more
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Currently have health insurance
Yes
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Currently have health insurance
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
WIC participation during pregnancy
Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
WIC participation during pregnancy
No
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Reported immediate biological family member ever diagnosed with or treated for diabetes
Yes
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Reported immediate biological family member ever diagnosed with or treated for diabetes
No
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Pregnancy trimester at study entry
1st trimester
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Pregnancy trimester at study entry
2nd trimester
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Pregnancy trimester at study entry
3rd trimester
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Number of live births (not including current pregnancy)
None
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Number of live births (not including current pregnancy)
1 birth
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Number of live births (not including current pregnancy)
2 births
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Number of live births (not including current pregnancy)
3 births
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Number of live births (not including current pregnancy)
4 or more births
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Number of stillbirths
None
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Number of stillbirths
One
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Number of stillbirths
Did not answer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Had a preterm delivery (baby was born before 37 weeks of pregnancy)
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Had a preterm delivery (baby was born before 37 weeks of pregnancy)
No
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Type of diabetes (if diagnosed with pregestational diabetes)
Type 1 diabetes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of diabetes (if diagnosed with pregestational diabetes)
Type 2 diabetes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of diabetes (if diagnosed with pregestational diabetes)
Not diagnosed with pregestational diabetes
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Smoking status
Not currently smoking
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Smoking status
Currently smoking
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline and at delivery through 6 months postpartumPopulation: We were unable to collect weight at certain time points for some participants.
The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=8 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Change in Weight
Baseline - delivery (GWG)
|
7.5 kgs
Interval 5.7 to 10.2
|
13.4 kgs
Interval 9.4 to 18.3
|
18.2 kgs
Interval 8.6 to 22.8
|
|
Change in Weight
Delivery - 6 month postpartum
|
-5.6 kgs
Interval -6.4 to -3.1
|
-12.3 kgs
Interval -13.7 to -7.9
|
-11.2 kgs
Interval -15.5 to -4.3
|
|
Change in Weight
Baseline - 6 month postpartum
|
4.1 kgs
Interval 2.0 to 5.7
|
3.5 kgs
Interval 3.4 to 7.2
|
5.9 kgs
Interval 4.0 to 10.3
|
PRIMARY outcome
Timeframe: At baseline and at 6 months postpartumPopulation: We were unable to collect HbA1c at certain time points for some participants.
The study team will measure mean blood glucose at baseline and at 6 months postpartum.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=9 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Change in HbA1c
Baseline
|
5.2 mmol/mol
Interval 4.7 to 5.4
|
5.2 mmol/mol
Interval 4.8 to 5.8
|
5.0 mmol/mol
Interval 5.0 to 5.2
|
|
Change in HbA1c
6 months
|
5.3 mmol/mol
Interval 5.2 to 5.4
|
5.4 mmol/mol
Interval 5.0 to 5.7
|
5.1 mmol/mol
Interval 5.0 to 5.2
|
PRIMARY outcome
Timeframe: At baseline, at delivery, and at 6 months postpartumPopulation: We were unable to collect arterial blood pressure at certain time points for some participants.
The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=10 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Change in Arterial Blood Pressure
Baseline
|
85.0 mmHg
Interval 82.0 to 85.3
|
90.7 mmHg
Interval 77.7 to 94.0
|
89.7 mmHg
Interval 86.7 to 95.3
|
|
Change in Arterial Blood Pressure
6 months
|
92.7 mmHg
Interval 87.3 to 94.0
|
91.3 mmHg
Interval 81.3 to 98.7
|
90.8 mmHg
Interval 85.0 to 95.0
|
PRIMARY outcome
Timeframe: At delivery through 6 months postpartumThe study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=10 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Duration of Breastfeeding
10 days · Still Breastfeeding
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Duration of Breastfeeding
10 days · No longer breastfeeding
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Duration of Breastfeeding
6 weeks · Still Breastfeeding
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Duration of Breastfeeding
6 weeks · No longer breastfeeding
|
2 Participants
|
7 Participants
|
6 Participants
|
|
Duration of Breastfeeding
3 months · Still Breastfeeding
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Duration of Breastfeeding
3 months · No longer breastfeeding
|
2 Participants
|
8 Participants
|
7 Participants
|
|
Duration of Breastfeeding
6 months · Still Breastfeeding
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Duration of Breastfeeding
6 months · No longer breastfeeding
|
3 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 6 months postpartumTo assess levels of self-efficacy. Survey consists of 14 items. All items are preceded by the phrase "I can always" and are anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. All items are presented positively, and scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=10 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
Baseline
|
33.0 score on a scale
Interval 28.0 to 50.0
|
35.0 score on a scale
Interval 20.0 to 44.0
|
41.0 score on a scale
Interval 32.0 to 49.0
|
|
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
6 months
|
49.0 score on a scale
Interval 26.0 to 52.0
|
52.0 score on a scale
Interval 27.0 to 70.0
|
62.5 score on a scale
Interval 30.0 to 65.0
|
SECONDARY outcome
Timeframe: At baseline and at 6 months postpartumTo assess multiple domains of physical activity and total physical activity before and after pregnancy. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5 (scores ranged from 1 for "never" or "none" to 5 for "always" or "more than once a week" in each physical activity domain). Higher scores indicate greater overall activity levels. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index\*0.25 + occupational index\*0.25 + active living index\*0.25 + sports/exercise index\*0.25) \* 4. The total activity score has a potential range of 4 - 20 with a mean of 10.42 (SD=2.00). A higher total activity score indicates a greater activity level.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=10 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Kaiser Physical Activity Survey (KPAS, Weighted Total)
Baseline
|
12.1 score on a scale
Interval 12.0 to 12.9
|
10.1 score on a scale
Interval 9.3 to 11.1
|
10.6 score on a scale
Interval 9.7 to 11.3
|
|
Kaiser Physical Activity Survey (KPAS, Weighted Total)
6 months
|
12.4 score on a scale
Interval 11.7 to 15.1
|
12.2 score on a scale
Interval 10.0 to 13.4
|
10.6 score on a scale
Interval 9.7 to 11.3
|
SECONDARY outcome
Timeframe: At baseline and at 6 months postpartumTo assess intake of fruits and vegetables before and after pregnancy. Survey consists of 10 items; with portion-size questions. Each question has two parts, asking over the last month how often a particular item was consumed (i.e.: never, 1-3x/mo, 1-2x/wk, etc.) and how much was usually consumed (i.e.: \<3/4cup, 3/4 to 1 1/4 cup, \>2 cups, etc.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=10 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Fruit & Vegetable Intake Screener (EATS)
Baseline
|
1.6 score on a scale
Interval 1.2 to 2.8
|
1.8 score on a scale
Interval 1.1 to 2.5
|
1.9 score on a scale
Interval 1.3 to 2.7
|
|
Fruit & Vegetable Intake Screener (EATS)
6 months
|
1.9 score on a scale
Interval 1.4 to 2.2
|
1.8 score on a scale
Interval 1.3 to 2.7
|
3.1 score on a scale
Interval 1.9 to 4.5
|
SECONDARY outcome
Timeframe: PostpartumTo assess levels of depression during the postpartum period. Survey consists of 10 items. Questions 1, 2, \& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3, 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score is 30. A score of 10 or higher generally indicates a potential need for further assessment regarding possible depression, while scores above 12 or 13 may suggest a higher likelihood of depression requiring medical attention. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up.
Outcome measures
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=5 Participants
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=11 Participants
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=10 Participants
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS)
Week 3
|
7 score on a scale
Interval 6.0 to 8.0
|
6 score on a scale
Interval 2.0 to 6.0
|
5 score on a scale
Interval 4.0 to 9.0
|
|
Edinburgh Postnatal Depression Scale (EPDS)
Week 6
|
7.5 score on a scale
Interval 6.5 to 10.0
|
6 score on a scale
Interval 0.0 to 9.0
|
4 score on a scale
Interval 1.5 to 4.0
|
|
Edinburgh Postnatal Depression Scale (EPDS)
Week 12
|
9 score on a scale
Interval 6.5 to 13.5
|
6 score on a scale
Interval 0.0 to 7.0
|
3 score on a scale
Interval 1.0 to 5.0
|
|
Edinburgh Postnatal Depression Scale (EPDS)
Month 6
|
7.5 score on a scale
Interval 5.5 to 9.5
|
4 score on a scale
Interval 1.0 to 9.0
|
3 score on a scale
Interval 1.0 to 4.0
|
Adverse Events
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention 2 (Tx2) - DPP Only + Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention 3 (Tx3) - Usual Care Only
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
n=9 participants at risk
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 2 (Tx2) - DPP Only + Usual Care
n=14 participants at risk
Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
Intervention 3 (Tx3) - Usual Care Only
n=12 participants at risk
Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected from the time of enrollment through 6 months postpartum follow up.
|
0.00%
0/14 • Adverse event data was collected from the time of enrollment through 6 months postpartum follow up.
|
8.3%
1/12 • Number of events 1 • Adverse event data was collected from the time of enrollment through 6 months postpartum follow up.
|
Other adverse events
Adverse event data not reported
Additional Information
Lisette T. Jacobson, Ph.D., MPA, M.A., Associate Professor, Obstetrics and Gynecology
University of Kansas Medical Center
Phone: 316-293-3484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place