Trial Outcomes & Findings for Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery (NCT NCT01439802)

NCT ID: NCT01439802

Last Updated: 2023-04-07

Results Overview

Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: 6 week postpartum
• Results posted on: 2023-04-07

Participant Flow

Recruitment took place in two Bronx medical centers. During prenatal care, all women were counseled regarding contraception. Women who intended to use the copper T380A IUD postpartum were approached and informed about the study after arriving on labor and delivery. Women undergoing cesarean delivery at >= 35 weeks of gestation and who met all of the inclusion and none of the exclusion criteria were enrolled into the study upon signing informed consent.

Participant milestones

Measure	Postplacental Insertion of Intrauterine Device (IUD) This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
6 Weeks Postpartum Status STARTED	90
6 Weeks Postpartum Status COMPLETED	54
6 Weeks Postpartum Status NOT COMPLETED	36
6 Months Postpartum Status STARTED	54
6 Months Postpartum Status COMPLETED	42
6 Months Postpartum Status NOT COMPLETED	12

Reasons for withdrawal

Measure	Postplacental Insertion of Intrauterine Device (IUD) This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
6 Weeks Postpartum Status Lost to Follow-up	36
6 Months Postpartum Status Lost to Follow-up	12

Baseline Characteristics

Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

Baseline characteristics by cohort

Measure	Postplacental Insertion of Intrauterine Device (IUD) n=90 Participants This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
Age, Customized <20 years old	2 Participants n=5 Participants
Age, Customized 20-29 years old	40 Participants n=5 Participants
Age, Customized 30-39 years old	45 Participants n=5 Participants
Age, Customized 40-49 years old	3 Participants n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	31 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	46 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Not Specified	7 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants
Parity Nulliparous	4 Participants n=5 Participants
Parity Multiparous	86 Participants n=5 Participants
Indication Elective Repeat	66 Participants n=5 Participants
Indication Shoulder Dystocia	5 Participants n=5 Participants
Indication Macrosomia	8 Participants n=5 Participants
Indication Malpresentation	5 Participants n=5 Participants
Indication Preeclampsia	3 Participants n=5 Participants
Indication Other	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 week postpartum

Population: Fifty-four (54) of ninety (90) participants were able to be reached for a response at 6 weeks either in person or via telephone.

Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

Outcome measures

Measure	Postplacental Insertion of Intrauterine Device (IUD) n=54 Participants This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
Number of Participants With Expulsion of IUD IUD Maintained	54 Participants
Number of Participants With Expulsion of IUD IUD Expelled	0 Participants

SECONDARY outcome

Timeframe: 6 months postpartum

Population: Forty-two (42) of the ninety (90) enrolled participants were able to be reached at 6 months following IUD placement.

Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD.

Outcome measures

Measure	Postplacental Insertion of Intrauterine Device (IUD) n=42 Participants This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
Satisfaction of IUD Placement Very Happy/Happy	34 Participants
Satisfaction of IUD Placement Somewhat Happy	4 Participants
Satisfaction of IUD Placement Unsure	4 Participants
Satisfaction of IUD Placement Unhappy	0 Participants

SECONDARY outcome

Timeframe: 6 months postpartum

Population: Forty-two (42) of ninety (90) participants were able to reached at 6 months following IUD placement.

Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

Outcome measures

Measure	Postplacental Insertion of Intrauterine Device (IUD) n=42 Participants This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
Number of Participants With Expulsion of IUD IUD Maintained	42 Participants
Number of Participants With Expulsion of IUD IUD Expelled	0 Participants

Adverse Events

Postplacental Insertion of Intrauterine Device (IUD)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Postplacental Insertion of Intrauterine Device (IUD) n=42 participants at risk This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion.
Pregnancy, puerperium and perinatal conditions Heavy menstrual bleeding	14.3% 6/42 • Number of events 6 • 6 months postpartum
Pregnancy, puerperium and perinatal conditions Cramping	40.5% 17/42 • Number of events 17 • 6 months postpartum

Additional Information

Dr. Erika Levi

Albert Einstein College of Medicine

Phone: 718-405-8260

Email: elevi@montefiore.org

Results disclosure agreements

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