Clinical trial NCT01293760: Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion
Official title: Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: intrauterine device
contraception
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Mulago Hospital, Uganda
name: Brigham and Women's Hospital
name: Society of Family Planning
First posted: 2011-02-11
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

1. Pregnant at time of enrollment
2. Scheduled to undergo non-emergent cesarean delivery
3. Will have to wait at least 8 hours before their cesarean section
4. Are not in active labor
5. Desires to use the Copper T 380A for contraception
6. Willing and able to sign an informed consent
7. Willing to comply with the study protocol
8. Age greater than or equal to 18 years
9. English or Luganda speaking
10. 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.

Exclusion Criteria:

1. Allergy to copper or pelvic tuberculosis, severe thrombocytopenia
2. Positive N. gonorrheae or C. trachomatis testing
3. Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the Copper T 380A
4. Uterine anomaly which would not allow placement of the Copper T 380A
5. Current cervical cancer or carcinoma in-situ
6. Desire for repeat pregnancy in less than 12 months
7. Evidence of intra-uterine infection (Chorioamnionitis)
8. Pre-term birth prior to 34 weeks of gestation
9. Diagnosis of AIDS (HIV is not an exclusion criteria)
10. Fetal demise
11. Antepartum hemorrhage
12. Ruptured uterus
13. Eclampsia
14. Evidence of severe anemia

Post enrollment exclusion criteria

1. Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; severe anemia)
2. 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
3. Group 1: Prolonged rupture of membranes \> 12 hours
4. Group 2: Diagnosis of active cervical infection within 3 months of planned insertion, or evidence of active pelvic or cervical infection, pus at the cervical os or any concern for upper genital tract infection, including fever (temperature ≥ 38° C) or uterine or adnexal tenderness. Diagnosis of new pregnancy.
5. Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
6. Both Groups: Participant no longer desires a Copper T 380A

Primary outcomes:
measure: 6 month IUD usage rates
timeFrame: 6 months
Secondary outcomes:
measure: IUD Expulsion
timeFrame: within 6 months
measure: IUD Removal
timeFrame: within six months
measure: IUD insertion
timeFrame: within 6 months
measure: Pregnancy
timeFrame: within 6 months
measure: Infection
timeFrame: within 6 months
measure: Uterine Perforation
timeFrame: within 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.