A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

Contraception Clinical Trial

Official title:

A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01161095
• Other study ID #: NMCP.2010.0074
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2010
• Est. completion date: May 28, 2014

Study information

• Verified date: May 2024
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).

Description:

The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.

The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.

Secondary outcome measures that we will obtain include:

• Pain at the time of placement

• Postpartum Depression

• Breastfeeding status

• Postpartum weight retention

• Expulsion Rates

• Bleeding Profile

• Uterine Infection(Endometritis)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: May 28, 2014
• Est. primary completion date: May 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.

Exclusion Criteria:

Contraindications to the LNG-IUS include:

• Pregnancy or suspicion of pregnancy

• Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity

• Postpartum endometritis within the past 3 months

• Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear

• untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections

• acute liver disease or liver tumor

• hypersensitivity to any component of the product

• known or suspected carcinoma of the breast

Any of these conditions would exclude the patient from receiving these forms of contraception in our study.

In addition the following intrapartum findings, the following would exclude the patient:

• Delivery <37 weeks

• Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid

• Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery or >1000cc for cesarean delivery)

Related Conditions & MeSH terms

• Contraception
• Postpartum Period

Intervention

Device:
• LNG-IUS
Mirena (Bayer)- Levonorgestrel-Intrauterine System

Locations

Country	Name	City	State
United States	University of Arkansas for the Medical Sciences	Little Rock	Arkansas
United States	Naval Medical Center	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuation Rates	Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum).; Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.	6 months
Secondary	Pain at insertion	Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.	1 minute
Secondary	Postpartum Depression	Depression history will be determined from the initial data collection sheet upon entry into the study. The Edinburgh Postnatal Depression Scale will be filled out by the participant at their six week postpartum appointment (routine), and also at six months.	6 months
Secondary	Breastfeeding Status	We will identify those who plan on breastfeeding their infants prior to discharge from the hospital. We will also determine the number of hours to Lactogenesis II (avg 40-50 hrs) via phone interview within one week from discharge. We will determine discontinuation rates and days to discontinuation of breastfeeding at six weeks and six months. We will also record infant weights at the postpartum appointment and at six months.	6 months
Secondary	Postpartum weight retention	We will determine each participant's pre pregnancy BMI, BMI at admission to labor and delivery, and BMI at the postpartum appointment and at 6 months.	6 months
Secondary	Sexual Function	We will determine the number of days from delivery to resumption of sexual intercourse. We will also have the participant complete the Female Sexual Function Index questionnaire (FSFI) at the postpartum appointment and at 6 months.	6 months
Secondary	Expulsion Rate	Expulsion rate as well as resumption of contraception (whether LNG-IUS is replaced or another form of contraception is initiated) occurs at the postpartum appointment and at six months	6 months
Secondary	Bleeding Profile	Each Participant will be asked to complete a monthly menstrual flow calendar to document light, medium, or heavy bleeding. These will be collected at the postpartum appointment and at six months.	6 months
Secondary	Infectious morbidity	Postpartum endometritis and pelvic inflammatory disease will be tracked with record review and direct participant questioning at their postpartum appointment and at six months	6 months