A Pilot Study of Early Postpartum Intrauterine Contraception (ImmPPIUD)

• ClinicalTrials.gov Identifier: NCT00997932
• Recruitment Status: Completed
• First Posted: October 20, 2009
• Results First Posted: March 29, 2017
• Last Update Posted: March 29, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): Gretchen Stuart, MD, University of North Carolina, Chapel Hill

Study Description

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Pilot Study of Early Postpartum Intrauterine Contraception
• Study Start Date: June 2009
• Actual Primary Completion Date: October 2010
• Actual Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

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

Investigators

• 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
• ClinicalTrials.gov Identifier: NCT00997932
• Other Study ID Numbers: SFP3-14
• First Posted: October 20, 2009
• Results First Posted: March 29, 2017
• Last Update Posted: March 29, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• 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; Levonorgestrel; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral