Postpartum Intrauterine Device Study

NCT ID: NCT01175161

Last Updated: 2011-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-06-30

Brief Summary

The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.

The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.

Detailed Description

Women will be enrolled into the study during prenatal care. After delivery, if they meet secondary eligibility criteria, they will be randomized to receive the IUD immediately postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks after IUD insertion, and be assessed at those time points for satisfaction with the method and IUD expulsion.

Conditions

Contraception; Intrauterine Devices; Pilot Study; Africa

Keywords

Postpartum Contraception; Intrauterine device; feasibility; IUD; Immediate postpartum IUD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Immediate postpartum IUD insertion

Women assigned to have the IUD placed 10 minutes to 48 hours postpartum

Group Type: EXPERIMENTAL

Copper T380A Intrauterine Device

Intervention Type: DEVICE

the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.

6 week postpartum IUD insertion

Women who receive the IUD at the traditional time frame.

Group Type: EXPERIMENTAL

Copper T380A Intrauterine Device

Intervention Type: DEVICE

the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.

Interventions

Copper T380A Intrauterine Device

the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 18-45 attending prenatal care
• Greater than 34 weeks estimated gestational age
• Desire to use the CuT380A-IUCD for contraception postpartum
• Plan to stay in the area for at least 5 months postpartum
• If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport
• No prior cesarean delivery
• No treatment for pelvic inflammatory disease within 3 months prior to pregnancy
• No known uterine anomalies
• No known pelvic tuberculosis
• No known genital tract cancer
• No known allergy to copper
• No known history of ectopic pregnancy within 3 months prior to pregnancy.
• No evidence of clinical anemia as assessed by a clinician at enrollment
• Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery

Secondary Eligibility Criteria

• Vaginal delivery within the last 48 hours
• No postpartum hemorrhage documented by the delivering clinician
• Not known to have ruptured membranes for greater than 24 hours prior to delivery
• No infection diagnosed by a clinician
• No fever of greater than 38° during labour or delivery
• Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.

Exclusion Criteria

• prior cesarean section
• fever during labor and delivery
• AIDS, not well on antiretroviral therapy
• genital tuberculosis
• known uterine abnormalities or genital tract cancer
• history of ectopic pregnancy within 3 months of current pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Amy Bryant

Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy G Bryant, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Gretchen S Stuart, MD, MPHTM

Role: STUDY_DIRECTOR

University of Carolina Chapel Hill

Locations

University of North Carolina Project Lilongwe

Lilongwe, , Malawi

Countries

Malawi

References

Bryant AG, Kamanga G, Stuart GS, Haddad LB, Meguid T, Mhango C. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial. Afr J Reprod Health. 2013 Jun;17(2):72-9.

Reference Type: DERIVED

PMID: 24069753 (View on PubMed)

Other Identifiers

CID-0925

Identifier Type: -

Identifier Source: org_study_id