Quick Start Approach to Birth Control Pills

Pregnancy Clinical Trial

Official title:

RCT of a Novel Oral Contraceptive Initiation Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068848
• Other study ID #: HD42413
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2003
• Last updated: April 9, 2007
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: April 2007
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Women who choose to take birth control pills are currently instructed to begin taking the pills at the end of a menstrual cycle. This creates a window of time between when the woman is given the pills and when she begins taking them. Some women fail to begin taking the pills, placing them at increased risk of pregnancy. This study will evaluate a new approach to beginning birth control pills. Women will take the first pill in the doctor’s office rather than waiting until the next menstrual cycle.

Description:

Despite the effectiveness of oral contraceptives, pregnancy rates are high among women who choose this method of birth control. These pregnancies occur due to incorrect use, premature discontinuation, and failure to begin taking oral contraceptives after they have been prescribed. As many as 25% of adolescents who seek oral contraceptives from family planning clinics never take the first pill. Failure to begin oral contraceptives may occur due to ambivalence, confusion about starting instructions, or intervening pregnancy. Conventional starting instructions for oral contraceptives require waiting until the next menstrual period; this may leave the woman at high risk of pregnancy. This trial will evaluate a "quick start" approach in which the woman swallows the first pill during the clinic visit under direct observation and then continues daily pill use without waiting for her next menses. The trial will determine whether immediate oral contraceptive initiation offers benefits compared to conventional starting approaches.

Participants in this study will be randomized to receive either the quick start or the standard starting approach. Participants will complete a questionnaire at study entry and Months 3 and 6. The main outcomes are 6-month oral contraceptive continuation rates and pregnancy rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 24 Years

Eligibility

Inclusion Criteria

• Requests hormonal contraceptives as primary method of contraception

• Sexually active (intercourse within 30 days prior to study entry) or anticipating sexual activity within 30 days following study entry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception
• Pregnancy

Intervention

Behavioral:
• Quick start oral contraceptive initiation

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Mt. Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,