A Pilot Study of Early Postpartum Intrauterine Contraception (ImmPPIUD)

This study has been completed.

Sponsor:

Information provided by:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00997932

First received: September 28, 2009

Last updated: December 13, 2012

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2009

Last Updated Date

December 13, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IUD expulsion [ Time Frame: From time of insertion to final study date which is 6 months after IUD insertion. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00997932 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Feasibility of enrollment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Pilot Study of Early Postpartum Intrauterine Contraception

Official Title ^ICMJE

A Pilot Study of Early Postpartum Intrauterine Contraception

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Unplanned Pregnancy

Intervention ^ICMJE

Device: Mirena Intrauterine Contraceptive System

Postpartum placement of the IUD

Other Names:

Intrauterine device
Mirena
Intrauterine contraception

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

21 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00997932

Other Study ID Numbers ^ICMJE

SFP3-14

Has Data Monitoring Committee

Responsible Party

Gretchen S. Stuart, MD, MPHTM Assistant Professor of Obstetrics and Gynecology, University of North Carolina at Chapel Hill

Study Sponsor ^ICMJE

University of North Carolina, Chapel Hill

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gretchen Stuart, MD

University of North Carolina, Chapel Hill

Information Provided By

University of North Carolina, Chapel Hill

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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