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Completed

NCT Number: NCT01293760

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

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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mulago Hospital

Kampala, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Diagnosis of AIDS (HIV is not an exclusion criteria)
  • Fetal demise
  • Antepartum hemorrhage
  • Ruptured uterus
  • Eclampsia
  • Evidence of severe anemia

Post enrollment exclusion criteria

  • Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; 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
  • 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.
  • Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
  • Both Groups: Participant no longer desires a Copper T 380A

Treatment and study plan

Immediate insertion

Other

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

6 weeks interval insertion

Other

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

Primary outcomes

  1. 6 month IUD usage rates

    Time frame: 6 months

    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

Secondary outcomes

  1. IUD Expulsion

    Time frame: within 6 months

    The time until expulsion of the Copper T 380A will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the Copper T 380A is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial

  2. IUD Removal

    Time frame: within six months

    The proportion of participants who have the Copper T 380A inserted and who deliberately have it removed. We will also analyze the time to removal for these participants

  3. IUD insertion

    Time frame: within 6 months

    The proportion of participants receiving a Copper T 380A in each group

  4. Pregnancy

    Time frame: within 6 months

    Time to pregnancy will be calculated from the date of delivery until the estimated date of conception of a subsequent pregnancy, as based on sonographic dating. If sonographic dating is not available, the date of the last missed menses or three weeks before the first positive urine pregnancy test (if amenorrheic or oligomenorrheic) will be used

  5. Infection

    Time frame: within 6 months

    The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study

  6. Uterine Perforation

    Time frame: within 6 months

    The diagnosis of a perforation may be made by a transvaginal sonogram that shows no Copper T 380A within the uterus and an abdominal radiograph that shows a Copper T 380A within the abdominal cavity

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Brigham and Women's Hospital
  • Mulago Hospital, Uganda
  • Society of Family Planning

Registry information

Official study title

Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2011
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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