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A Pilot Study of Early Postpartum Intrauterine Contraception (ImmPPIUD)

This study has been completed.
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill Identifier:
First received: September 28, 2009
Last updated: March 28, 2017
Last verified: March 2017

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.

Condition Intervention Phase
Unplanned Pregnancy
Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: A Pilot Study of Early Postpartum Intrauterine Contraception

Resource links provided by NLM:

Further study details as provided by Gretchen Stuart, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • IUD Expulsion [ Time Frame: From time of insertion to final study date which is 6 months after IUD insertion. ]
    Expulsion of the LNG-IUS

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: November 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Complete Cohort
The complete cohort of all women enrolled and stated they wanted an LNG-IUS between 48 and 72 hours of vaginal delivery.
Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours
Other Name: LNG-IUS

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.


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00997932

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Gretchen Stuart, MD, MPHTM University of North Carolina, Chapel Hill
  More Information

Responsible Party: Gretchen Stuart, MD, MD, University of North Carolina, Chapel Hill Identifier: NCT00997932     History of Changes
Other Study ID Numbers: SFP3-14
Study First Received: September 28, 2009
Results First Received: January 11, 2017
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gretchen Stuart, MD, University of North Carolina, Chapel Hill:
levonorgestrel releasing intrauterine device
levonorgestrel releasing intrauterine contraception
unintended pregnancy prevention
postpartum contraception

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on May 25, 2017