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

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ClinicalTrials.gov Identifier: NCT01309919
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Postpartum Period Device: IUD Other: Diary

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bleeding Patterns and Complications After Postpartum Intrauterine Device (IUD) Placement: a Pilot Study
Study Start Date : January 2011
Primary Completion Date : December 2011
Study Completion Date : February 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Bleeding Patterns [ Time Frame: 12 weeks post-partum ]
    Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum


Secondary Outcome Measures :
  1. Expulsions [ Time Frame: 6 months ]
    Incidence of spontaneous IUD expulsion in the six months after insertion

  2. Satisfaction [ Time Frame: 12 weeks post-partum ]
    Participant satisfaction with the IUD at 12 weeks post-insertion

  3. Insertion Time [ Time Frame: immediate ]
    Time of insertion of the IUD


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 7, 2011    Key Record Dates
Results First Posted: January 29, 2015
Last Update Posted: January 29, 2015
Last Verified: January 2015

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