A Pilot Study of Early Postpartum Intrauterine Contraception

NCT00997932 | Completed Phase 4 Results FDA Drug

• 1 other identifier: SFP3-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Unplanned Pregnancy

Keywords

levonorgestrel releasing intrauterine device; levonorgestrel releasing intrauterine contraception; unintended pregnancy prevention; postpartum contraception

Outcome Measures

Primary Outcomes (1)

• IUD Expulsion

  Expulsion of the LNG-IUS

  From time of insertion to final study date which is 6 months after IUD insertion.

Study Arms (1)

Complete Cohort

OTHER

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

Interventions

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

Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours

Also known as: LNG-IUS

Complete Cohort

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Time

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Dr. G Stuart
• Organization: University of North Carolina School of Medicine

gstuart@med.unc.edu

919-962-4880

Study Officials

• Gretchen Stuart, MD, MPHTM

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: October 20, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2012
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)