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

NCT01293760 | Completed

• 1 other identifier: 2010p001355
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intrauterine device; contraception

Outcome Measures

Primary Outcomes (1)

• 6 month IUD usage rates

  The number of participants enrolled who are using the Copper T 380A at 6 months post-delivery. This will include participants who are excluded at time of delivery or interval insertion and participants who do not follow up for interval Copper T 380A insertion

  6 months

Secondary Outcomes (6)

• IUD Expulsion

  within 6 months

• IUD Removal

  within six months

• IUD insertion

  within 6 months

• Pregnancy

  within 6 months

• Infection

  within 6 months

Study Arms (2)

6 weeks interval insertion

OTHER

IUD is inserted 6 weeks following c-section delivery of baby and placenta

Other: 6 weeks interval insertion

Immediate insertion

EXPERIMENTAL

IUD is inserted immediately following c-section delivery of baby and placenta

Other: Immediate insertion

Interventions

Immediate insertion OTHER

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

Immediate insertion

6 weeks interval insertion OTHER

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

6 weeks interval insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant at time of enrollment
• Scheduled to undergo non-emergent cesarean delivery
• Will have to wait at least 8 hours before their cesarean section
• Are not in active labor
• Desires to use the Copper T 380A for contraception
• Willing and able to sign an informed consent
• Willing to comply with the study protocol
• Age greater than or equal to 18 years
• English or Luganda speaking
• Willing to be accompanied home upon discharge from the hospital and have their address recorded in order to be able to visit them at home at 6 months postpartum if they do not return for their 6 month follow-up visit.

You may not qualify if:

• Allergy to copper or pelvic tuberculosis, severe thrombocytopenia
• Positive N. gonorrheae or C. trachomatis testing
• Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the Copper T 380A
• Uterine anomaly which would not allow placement of the Copper T 380A
• Current cervical cancer or carcinoma in-situ
• Desire for repeat pregnancy in less than 12 months
• Evidence of intra-uterine infection (Chorioamnionitis)
• Pre-term birth prior to 34 weeks of gestation
• Fetal demise
• Antepartum hemorrhage
• Ruptured uterus
• Eclampsia
• Evidence of severe anemia
• Group 1: Post-partum hemorrhage with continued active bleeding that does not allow placement of the Copper T 380A within 10 minutes of the delivery of the placenta
• Group 1: Prolonged rupture of membranes \> 12 hours

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead
• Mulago Hospital, Uganda: collaborator
• Brigham and Women's Hospital: collaborator
• Society of Family Planning: collaborator

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (2)

• Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

  PMID: 36302159 DERIVED

• Lester F, Kakaire O, Byamugisha J, Averbach S, Fortin J, Maurer R, Goldberg A. Intracesarean insertion of the Copper T380A versus 6 weeks postcesarean: a randomized clinical trial. Contraception. 2015 Mar;91(3):198-203. doi: 10.1016/j.contraception.2014.12.002. Epub 2014 Dec 12.

  PMID: 25499587 DERIVED

Study Officials

• Principal Investigator

  Planned Parenthood League of Massachusetts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

UG (1)