Trial Outcomes & Findings for Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation (NCT NCT00540046)

NCT ID: NCT00540046

Last Updated: 2015-02-09

Results Overview

Number of participants using Copper T380A IUD 6 months after surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 215 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-02-09

Participant Flow

Participant milestones

Measure	A/Immediate The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.	B/Delayed The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Overall Study STARTED	104	111
Overall Study COMPLETED	71	88
Overall Study NOT COMPLETED	33	23

Reasons for withdrawal

Measure	A/Immediate The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.	B/Delayed The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Overall Study Lost to Follow-up	33	23

Baseline Characteristics

Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation

Baseline characteristics by cohort

Measure	A/Immediate n=104 Participants The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.	B/Delayed n=111 Participants The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit.	Total n=215 Participants Total of all reporting groups
Age, Continuous	24 years n=5 Participants	23.4 years n=7 Participants	23.7 years n=5 Participants
Sex/Gender, Customized Female	104 participants n=5 Participants	111 participants n=7 Participants	215 participants n=5 Participants
Race/Ethnicity, Customized Black	48 participants n=5 Participants	52 participants n=7 Participants	100 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	43 participants n=5 Participants	39 participants n=7 Participants	82 participants n=5 Participants
Race/Ethnicity, Customized White	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized Asian or South Asian	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Mixed	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Missing	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Gestational age	19.2 weeks n=5 Participants	18.8 weeks n=7 Participants	19.0 weeks n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants using Copper T380A IUD 6 months after surgery

Outcome measures

Measure	A/Immediate n=71 Participants The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.	B/Delayed n=88 Participants The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Use of IUD	58 participants	25 participants

SECONDARY outcome

Timeframe: 6 months

Population: The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.

IUD was not removed by provider but fell out on its own.

Outcome measures

Measure	A/Immediate n=64 Participants The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.	B/Delayed n=26 Participants The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Expulsion	3.1 percentage of expulsions	0 percentage of expulsions

Adverse Events

A/Immediate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

B/Delayed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	A/Immediate n=104 participants at risk The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.	B/Delayed n=111 participants at risk The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure. Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Reproductive system and breast disorders Expulsion	1.9% 2/104 • Number of events 2 • 6 months	0.00% 0/111 • 6 months

Additional Information

Miriam Cremer MD MPH

Basic Health International

Phone: (646) 593-8694

Email: miriam.cremer@gmail.com

Results disclosure agreements

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