A Pilot Study of Early Postpartum Intrauterine Contraception (ImmPPIUD)

University of North Carolina (UNC)

Status and phase

Completed

Phase 4

Conditions

Unplanned Pregnancy

Treatments

Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration

Study type

Interventional

Funder types

Other

Identifiers

NCT00997932

SFP3-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

21 to 45 years old

Volunteers

No Healthy Volunteers

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