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Quick Start Approach to Birth Control Pills



Quick Start Approach to Birth Control Pills

For Condition: Contraception,Pregnancy
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: /24 Years
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 2000

Location and Contact Information:

Overall Study Official:
CarolynWesthoff,  Principal Investigator,  Columbia University

Mt. Sinai School of Medicine *Recruiting*
New York City,  New York,  10128
United States
Recruiting  

Emory University School of Medicine *Recruiting*
Atlanta,  Georgia,  30303
United States
Recruiting  

University of Texas Southwestern Medical Center at Dallas *Recruiting*
Dallas,  Texas,  75235
United States
Recruiting  


Additional Information:
Study ID Numbers:
  HD42413; 
Study Start Date: February 2003
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068848

Other Pregnancy Studies:
1. A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

2. Ultrasound and motivational enhancement for prenatal smoking cessation

3. Effectiveness of BufferGel as a Vaginal Contraceptive

4. Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants

5. Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS.

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