Trial Outcomes & Findings for Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study (NCT NCT01309919)

NCT ID: NCT01309919

Last Updated: 2015-01-29

Results Overview

Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 12 weeks post-partum
• Results posted on: 2015-01-29

Participant Flow

Participant milestones

Measure	Intrauterine Device (IUD) Arm Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Overall Study STARTED	75	75
Overall Study COMPLETED	58	27
Overall Study NOT COMPLETED	17	48

Reasons for withdrawal

Measure	Intrauterine Device (IUD) Arm Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Overall Study Did not receive a postpartum IUD	17	48

Baseline Characteristics

Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study

Baseline characteristics by cohort

Measure	IUD Arm n=75 Participants Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm n=75 Participants Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months	Total n=150 Participants Total of all reporting groups
Age, Continuous	25 years STANDARD_DEVIATION 5 • n=5 Participants	24 years STANDARD_DEVIATION 5 • n=7 Participants	24.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants	38 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	37 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	53 participants n=5 Participants	49 participants n=7 Participants	102 participants n=5 Participants
Race/Ethnicity, Customized Black	8 participants n=5 Participants	14 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Other	14 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants
Body Mass Index	32.4 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	31.6 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	32 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post-partum

Population: We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)

Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum

Outcome measures

Measure	IUD Arm n=25 Participants Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm n=27 Participants Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Bleeding Patterns First 6 wks PP - Bleeding	15 days Interval 6.0 to 42.0	18 days Interval 8.0 to 42.0
Bleeding Patterns First 6 wks PP - Spotting	13 days Interval 0.0 to 29.0	7 days Interval 0.0 to 33.0
Bleeding Patterns Second 6wks PP - Bleeding	5.5 days Interval 0.0 to 42.0	8 days Interval 0.0 to 42.0
Bleeding Patterns Second 6wks PP - Spotting	7.5 days Interval 0.0 to 42.0	4 days Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 6 months

Population: We assessed the number of expelled IUDs for all participants who had an IUD placed

Incidence of spontaneous IUD expulsion in the six months after insertion

Outcome measures

Measure	IUD Arm n=58 Participants Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Expulsions	3 participants	—

SECONDARY outcome

Timeframe: 12 weeks post-partum

Population: We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call

Participant satisfaction with the IUD at 12 weeks post-insertion

Outcome measures

Measure	IUD Arm n=44 Participants Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Satisfaction Very satisfied	82 % of participants who received an IUD	—
Satisfaction Somewhat satisfied	11 % of participants who received an IUD	—

SECONDARY outcome

Timeframe: immediate

Time of insertion of the IUD

Outcome measures

Measure	IUD Arm n=58 Participants Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum. Diary: Subjects will keep a bleeding diary for three months	Diary Arm Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Insertion Time	5.5 minutes Standard Deviation 4.3	—

Adverse Events

IUD Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diary Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katharine White

Baystate Medical Center

Phone: 413-794-5256

Email: katharine.white@bhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place