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

NCT01309919 | Completed Results

• 1 other identifier: BH10-190
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Period

Keywords

intrauterine device; Mirena; levonorgestrel intrauterine system; postpartum contraception

Outcome Measures

Primary Outcomes (1)

• Bleeding Patterns

  Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum

  12 weeks post-partum

Secondary Outcomes (3)

• Expulsions

  6 months

• Satisfaction

  12 weeks post-partum

• Insertion Time

  immediate

Study Arms (2)

IUD Arm

ACTIVE COMPARATOR

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

Device: IUD; Other: Diary

Diary Arm

OTHER

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Other: Diary

Interventions

IUD DEVICE

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.

Also known as: Mirena intrauterine system

IUD Arm

Diary OTHER

Subjects will keep a bleeding diary for three months

Also known as: bleeding diary (three-month calendar)

Diary Arm; IUD Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Limitations and Caveats

Low rate of bleeding diary return limited our assessment of the primary outcome of bleeding/spotting days after delivery.

Results Point of Contact

• Title: Dr. Katharine White
• Organization: Baystate Medical Center

katharine.white@bhs.org

413-794-5256

Study Officials

• Katharine O White, MD, MPH

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General OB/GYN

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 7, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: January 29, 2015
• Results First Posted: January 29, 2015

Record last verified: 2015-01

Locations

US (1)