Trial Outcomes & Findings for A Pilot Study of Early Postpartum Intrauterine Contraception (NCT NCT00997932)
NCT ID: NCT00997932
Last Updated: 2017-03-29
Results Overview
Expulsion of the LNG-IUS
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
From time of insertion to final study date which is 6 months after IUD insertion.
Results posted on
2017-03-29
Participant Flow
All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
Participant milestones
| Measure |
Immediate Insertion
Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The results are presented for the 29 women who received the IUD. Baseline data are presented for the 29 women who received the IUD and the 11 women who did not.
Baseline characteristics by cohort
| Measure |
Immediate Insertion
n=29 Participants
Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours
|
|---|---|
|
Age, Continuous
|
23 years
n=5 Participants • The results are presented for the 29 women who received the IUD. Baseline data are presented for the 29 women who received the IUD and the 11 women who did not.
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Race/Ethnicity, Customized
Race · Black
|
9 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
|
Previous contraceptive use, marital status, employment,
Employed · Yes
|
2 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Previous contraceptive use, marital status, employment,
Employed · No
|
27 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Previous contraceptive use, marital status, employment,
Married or Cohabitating · Yes
|
9 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Previous contraceptive use, marital status, employment,
Married or Cohabitating · No
|
20 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Previous contraceptive use, marital status, employment,
Prior use of contraception · Yes
|
29 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
|
Previous contraceptive use, marital status, employment,
Prior use of contraception · No
|
0 Participants
n=5 Participants • All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
|
PRIMARY outcome
Timeframe: From time of insertion to final study date which is 6 months after IUD insertion.Expulsion of the LNG-IUS
Outcome measures
| Measure |
Immediate Insertion
n=29 Participants
Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours
|
|---|---|
|
IUD Expulsion
|
11 Participants
|
Adverse Events
Immediate Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No IUD Insertion
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. G Stuart
University of North Carolina School of Medicine
Phone: 919-962-4880
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place