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Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion

NCT01293760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-05-10

No results posted yet for this study

Summary

The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. The investigators hypothesize that this pilot study will be feasible in terms of recruitment, provision of care, and follow-up.

The study will be a pilot randomized controlled trial comparing outcomes of immediate post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be powered to detect a difference, but rather the investigators will enroll all eligible and interested women during the three-month enrollment period. Potential participants who do not choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.

Conditions

  • Contraception

Interventions

OTHER

Immediate insertion

Insertion of Copper T 380A immediately after c-section delivery of baby and placenta

OTHER

6 weeks interval insertion

Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta

Sponsors & Collaborators

  • Mulago Hospital, Uganda

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Society of Family Planning

    collaborator OTHER

  • Planned Parenthood League of Massachusetts

    lead OTHER

Principal Investigators

  • Principal Investigator · Planned Parenthood League of Massachusetts

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01293760 on ClinicalTrials.gov