Trial Outcomes & Findings for Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section (NCT NCT00733278)

NCT ID: NCT00733278

Last Updated: 2014-08-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2014-08-11

Participant Flow

Women in prenatal clinic were approached in the third trimester if they were to be scheduled for elective C-section. If they were interested in using Copper IUD, their informed consent was obtained. At the time of elective C-section, their continued interest in study participation was verified.

Participant milestones

Measure	Copper IUD Women undergoing elective C-section who request long-term contraception with Copper IUD.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section

Baseline characteristics by cohort

Measure	IUD Placement n=7 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	IUD Placement n=7 Participants IUD placement following removal of placenta at time of elective C-section
Successful Retention of IUD	7 participants

SECONDARY outcome

Timeframe: At 3 days, 2 weeks and 6 weeks postpartum

Outcome measures

Measure	IUD Placement n=7 Participants IUD placement following removal of placenta at time of elective C-section
Visibility Within the Vagina of IUD Strings at All Times.	7 participants

Adverse Events

Copper IUD

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. Anita Nelson

LA BioMed

Email: anitanelsonwhc@earthlink.net

Results disclosure agreements

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