A Pilot Study of Early Postpartum Intrauterine Contraception (ImmPPIUD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00997932
First received: September 28, 2009
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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
Device: Mirena Intrauterine Contraceptive System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Early Postpartum Intrauterine Contraception

Resource links provided by NLM:


Further study details as provided by 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Feasibility of enrollment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
Experimental: Immediate insertion
Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 48 hours of delivery.
Device: Mirena Intrauterine Contraceptive System
Postpartum placement of the IUD
Other Names:
  • Intrauterine device
  • Mirena
  • Intrauterine contraception
Active Comparator: Interval insertion
Women in the interval insertion arm received a Mirena intrauterine contraceptive system four to six weeks after delivery at their standard postpartum visit.
Device: Mirena Intrauterine Contraceptive System
Postpartum placement of the IUD
Other Names:
  • Intrauterine device
  • Mirena
  • Intrauterine contraception

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997932

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

No publications provided

Responsible Party: Gretchen Stuart, MD, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00997932     History of Changes
Other Study ID Numbers: SFP3-14
Study First Received: September 28, 2009
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 28, 2014