Clinical trial NCT00997932: A Pilot Study of Early Postpartum Intrauterine Contraception
Official title: A Pilot Study of Early Postpartum Intrauterine Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unplanned Pregnancy
Keywords: levonorgestrel releasing intrauterine device
levonorgestrel releasing intrauterine contraception
unintended pregnancy prevention
postpartum contraception
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.

The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.

Detailed description: This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.

Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.

Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.

Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.

Eligibility criteria: Inclusion Criteria:

* Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.
* Desires to use intrauterine contraception (IUD) after delivery
* Anticipates having a vaginal delivery
* No intention to leave the area 7 months after enrollment
* Able to consent to participate in the study in English
* Has no known uterine anomalies
* Has no allergies to any components of the intrauterine contraception

Exclusion Criteria:

* Prior cesarean delivery
* Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
* Allergic to betadine
* Allergy to lidocaine
* Medical or personal conditions which in the judgment of study staff contradict participation in the study
* Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ
* After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:

  * Endometritis or chorioamnionitis during the intrapartum period
  * Membranes ruptured for greater than 24 hours prior to delivery
  * Fever greater than or equal to 38C
  * The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding

Primary outcomes:
measure: IUD Expulsion
timeFrame: From time of insertion to final study date which is 6 months after IUD insertion.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gretchen Stuart, MD, MPHTM
role: PRINCIPAL_INVESTIGATOR
References: