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

• Sponsor: Baystate Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01309919
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 11.5

Study Details

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	Phase
Postpartum Period	Device: IUD; Other: Diary	N/A

Detailed Description

This trial is a prospective two-arm cohort study to examine feasibility, complications, and patient satisfaction related to postpartum IUD placement, to be conducted at Baystate Medical Center (BMC).

There are two groups in this study. The first group is women who choose to have an IUD placed after delivery at BMC (IUD arm). The second group is women who decline an IUD but who will complete bleeding diaries for six-months postpartum (diary arm). We chose the LNG-IUS due to its high patient satisfaction rates and variety of non-contraceptive benefits.

The standard of care for postpartum contraception is to provide women with information about her choices during her pregnancy, and to provide her with a method at hospital discharge after delivery. We will approach women at their routine prenatal visits. Women will be counseled by their provider about the risks, benefits and alternatives of all of the available methods of birth control (pills, patch, ring, injection, implant, IUD and sterilization). We will provide written information about her choices. We will discuss in detail the issues surrounding postpartum IUD placement, which most women will not be familiar with as an option, and provide a detailed information sheet for her to take home. We will revisit the issue of contraception at each subsequent visit until the patient has made a decision about what method she wishes to use.

IUD ARM

All women who request postpartum IUD placement will be offered enrollment in the study in the IUD arm. If a patient wishes to enroll, we will obtain written informed consent for the study and the LNG-IUS. We will administer a brief demographic and contraceptive history questionnaire. Subjects will be given a prescription for the LNG-IUS to bring with them to the hospital at the time of their delivery. A notation about study involvement will be made in the problem list of the subject's electronic prenatal record, and she will be reminded by her provider at each subsequent visit to bring the IUD when she comes to the hospital for delivery.

The Mirena IUS (Bayer Pharmaceuticals) is a sterile, levonorgestrel-releasing (20 mcg/day) intrauterine system indicated for intrauterine contraception for up to 5 years. The local mechanism by which continuously released levonorgestrel enhances contraceptive effectiveness of Mirena has not been conclusively demonstrated. Studies of Mirena prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium.

All LNG-IUS insertions will be performed by the PI or by 2nd year obstetrics and gynecology residents. These residents all have experience with traditional IUD insertions, and they will be trained by the PI in postpartum IUD insertion. Training will involve a short lecture, practice insertions on a pelvic model, then observing a postpartum insertion by the PI.

Insertions will be performed at one of three times:

1. at the time of vaginal delivery, within 10 minutes of placental delivery (immediate placement);

2. at the time of cesarean delivery, within 10 minutes of placental delivery (immediate placement);

3. within 48 hours of either vaginal delivery or cesarean delivery (delayed placement).

At the time of vaginal delivery, the LNG-IUS will be inserted guided by trans-abdominal ultrasound to help ensure placement as close to the fundus as possible. If ultrasound is unavailable, another attempt at IUD placement will be made when the ultrasound becomes available.

At the time of cesarean delivery, the LNG-IUS will be placed prior to closure of the uterine incision.

At the time of delayed placement, subjects will be offered a dose of their routine postpartum pain medication (ibuprofen or oxycodone) prior to insertion. The LNG-IUS will be inserted guided by trans-abdominal ultrasound to help ensure placement as close to the fundus as possible. If ultrasound is unavailable, another attempt at IUD placement will be made when the ultrasound becomes available.

If a subject has not filled the prescription for the IUD by the time of delivery, we will submit an electronic prescription to the hospital pharmacy for the IUD, and the IUD may be picked up by a family member or friend and brought to L&D for placement. If a subject has left the IUD at home when she comes into the hospital for delivery, the IUD may be brought into the hospital by a family member or friend; if the IUD arrives at the hospital after delivery, she will be scheduled for a delayed postpartum placement. If the subject has been unable to obtain the IUD by 48 hours after delivery, she will be offered interval placement at the time of her postpartum visit.

All subjects will receive a bleeding diary to complete at home. We will call subjects at two weeks postpartum. During this telephone call we will ask questions regarding short term complications such as bleeding and signs of infection. If the subject has seen a medical professional before this phone call, or the LNG-IUS was expelled or removed, specific questions will be asked regarding these circumstances. At their six week postpartum visit, subjects will review their bleeding diary with study staff, complete a questionnaire and be evaluated for intrauterine IUD placement. If the tail strings are not visible a trans-vaginal ultrasound will be performed to assess placement. An intra-cervical LNG-IUS will be considered an expulsion and removal will be performed. Subjects will be counseled to return to clinic if they suspect expulsion at any time. We will provide stamped envelopes for subjects to mail back their bleeding diary at 12 weeks postpartum. We will call subjects at 12 weeks and six months postpartum regarding complications and specific questions about their satisfaction with the LNG-IUS.

DIARY-ONLY ARM

Women who do not want a postpartum IUD but who are interested in study participation will be offered enrollment in the diary-only arm. If a patient wishes to enroll, we will obtain written informed consent for the study and we will administer a brief demographic and contraceptive history questionnaire. Subjects will be given the bleeding diary to start after their discharge from the hospital after delivery. We will provide stamped envelopes for subjects to mail back their bleeding diary at 12 weeks postpartum.

Study Design

• Study Type: Interventional
• 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: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Feb 1, 2012

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 Names: Mirena intrauterine system ; Other: Diary; Subjects will keep a bleeding diary for three months; Other Names: bleeding diary (three-month calendar)
Other: 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 Names: bleeding diary (three-month calendar)

Outcome Measures

Primary Outcome Measures

1. Bleeding Patterns [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 [6 months]

   Incidence of spontaneous IUD expulsion in the six months after insertion

2. Satisfaction [12 weeks post-partum]

   Participant satisfaction with the IUD at 12 weeks post-insertion

3. Insertion Time [immediate]

   Time of insertion of the IUD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katharine White, Chief, Division of General OB/GYN, Baystate Medical Center
• ClinicalTrials.gov Identifier: NCT01309919
• Other Study ID Numbers: BH10-190
• First Posted: Mar 7, 2011
• Last Update Posted: Jan 29, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Katharine White, Chief, Division of General OB/GYN, Baystate Medical Center: intrauterine device; Mirena; levonorgestrel intrauterine system; postpartum contraception
• Additional relevant MeSH terms: Hemorrhage

Study Results

Participant Flow

Arm/Group Title	Intrauterine Device (IUD) Arm	Diary Arm
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months	Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Period Title: Overall Study
STARTED	75	75
COMPLETED	58	27
NOT COMPLETED	17	48

Baseline Characteristics

Arm/Group Title	IUD Arm	Diary Arm	Total
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months	Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months	Total of all reporting groups
Overall Participants	75	75	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (5)	24 (5)	24.5 (5)
Sex: Female, Male (Count of Participants)
Female	75 100%	75 100%	150 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	47 62.7%	38 50.7%	85 56.7%
Not Hispanic or Latino	27 36%	37 49.3%	64 42.7%
Unknown or Not Reported	1 1.3%	0 0%	1 0.7%
Race/Ethnicity, Customized (participants) [Number]
White	53 70.7%	49 65.3%	102 68%
Black	8 10.7%	14 18.7%	22 14.7%
Other	14 18.7%	12 16%	26 17.3%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.4 (7)	31.6 (7)	32 (7)

Outcome Measures

1. Primary Outcome

Title	Bleeding Patterns
Description	Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum
Time Frame	12 weeks post-partum

Outcome Measure Data

Analysis Population Description

We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)

Arm/Group Title	IUD Arm	Diary Arm
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months	Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Measure Participants	25	27
First 6 wks PP - Bleeding	15	18
First 6 wks PP - Spotting	13	7
Second 6wks PP - Bleeding	5.5	8
Second 6wks PP - Spotting	7.5	4

2. Secondary Outcome

Title	Expulsions
Description	Incidence of spontaneous IUD expulsion in the six months after insertion
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We assessed the number of expelled IUDs for all participants who had an IUD placed

Arm/Group Title	IUD Arm	Diary Arm
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months	Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Measure Participants	58	0
Number [participants]	3 4%

3. Secondary Outcome

Title	Satisfaction
Description	Participant satisfaction with the IUD at 12 weeks post-insertion
Time Frame	12 weeks post-partum

Outcome Measure Data

Analysis Population Description

We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call

Arm/Group Title	IUD Arm	Diary Arm
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months	Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Measure Participants	44	0
Very satisfied	82 109.3%
Somewhat satisfied	11 14.7%

4. Secondary Outcome

Title	Insertion Time
Description	Time of insertion of the IUD
Time Frame	immediate

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IUD Arm	Diary Arm
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months	Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
Measure Participants	58	0
Mean (Standard Deviation) [minutes]	5.5 (4.3)

Adverse Events

Time Frame	Adverse event data were collected for 6 months
Arm/Group Title	IUD Arm		Diary Arm
Arm/Group Description	Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) 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. Diary: Subjects will keep a bleeding diary for three months		Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all Diary: Subjects will keep a bleeding diary for three months
All Cause Mortality
	IUD Arm		Diary Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IUD Arm		Diary Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	IUD Arm		Diary Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.