Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katharine White, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01309919
First received: March 4, 2011
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to determine the feasibility of placing the levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The investigators will gain information about complications at the time of placement; the investigators will also examine the expulsion rate, side effects, bleeding patterns and subject satisfaction at various time periods after insertion.


Condition Intervention
Postpartum Period
Device: IUD
Other: Diary

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bleeding Patterns and Complications After Postpartum Intrauterine Device (IUD) Placement: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • feasibility of placing the levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery [ Time Frame: within 48 hours of delivery ] [ Designated as safety issue: No ]
    Assessment of the logistical issues surrounding postpartum IUD placement (availability of the IUD, securing equipment and ultrasound, ability to place the device)


Secondary Outcome Measures:
  • expulsion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    examine the incidence of spontaneous IUD expulsion in the six months after insertion

  • subject satisfaction [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    To examine subject satisfaction with both the IUD and the IUD insertion process, to be assessed at 3 and 6 months post-insertion

  • bleeding patterns [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to compare postpartum bleeding patterns of women who receive a postpartum Mirena with those of women who do not receive a Mirena.


Enrollment: 150
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IUD Arm
Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)
Device: IUD
Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
Other Name: Mirena intrauterine system
Other: Diary
Subjects will keep a bleeding diary for three months
Other Name: bleeding diary (three-month calendar)
Diary Arm
Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all
Other: Diary
Subjects will keep a bleeding diary for three months
Other Name: bleeding diary (three-month calendar)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years or older
  • speak either English or Spanish
  • desire to use an IUD as their postpartum contraception (IUD arm)
  • do NOT desire an IUD as their contraception (Diary Only arm)
  • plan to deliver at Baystate Medical Center.

Exclusion Criteria:

  • history of sexually transmitted infection during the three months prior to enrollment
  • desiring of another pregnancy within six months of giving birth
  • routine contraindications to IUD:
  • cavity-distorting uterine fibroids or uterine anomalies
  • known or suspected uterine or cervical neoplasia
  • acute liver disease or liver tumor
  • history of breast cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309919

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Katharine O White, MD, MPH Baystate Medical Center
  More Information

No publications provided

Responsible Party: Katharine White, Chief, Division of General OB/GYN, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01309919     History of Changes
Other Study ID Numbers: BH10-190
Study First Received: March 4, 2011
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
intrauterine device
Mirena
levonorgestrel intrauterine system
postpartum contraception

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014