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: January 22, 2015
Last verified: January 2015
  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:
  • Bleeding Patterns [ Time Frame: 12 weeks post-partum ] [ Designated as safety issue: No ]
    Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum


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

  • Satisfaction [ Time Frame: 12 weeks post-partum ] [ Designated as safety issue: No ]
    Participant satisfaction with the IUD at 12 weeks post-insertion

  • Insertion Time [ Time Frame: immediate ] [ Designated as safety issue: No ]
    Time of insertion of the IUD


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
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: 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
Results First Received: November 27, 2013
Last Updated: January 22, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 29, 2015