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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00068848 |
Purpose
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.
| Condition | Intervention | Phase |
|
Pregnancy Contraception |
Behavioral: Quick start oral contraceptive initiation |
Phase IV |
| MedlinePlus related topics: | Birth Control |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | RCT of a Novel Oral Contraceptive Initiation Method |
| Estimated Enrollment: | 2000 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | March 2005 |
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
| Ages Eligible for Study: | up to 24 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Contacts and Locations| United States, Georgia | |||||
| Emory University School of Medicine | |||||
| Atlanta, Georgia, United States, 30303 | |||||
| United States, New York | |||||
| Mt. Sinai School of Medicine | |||||
| New York, New York, United States, 10128 | |||||
| United States, Texas | |||||
| University of Texas Southwestern Medical Center at Dallas | |||||
| Dallas, Texas, United States, 75235 | |||||
| Principal Investigator: | Carolyn L. Westhoff, MD, MSc | Columbia University |
More Information
| Study ID Numbers: | HD42413 |
| First Received: | September 10, 2003 |
| Last Updated: | April 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00068848 |
| Health Authority: | United States: Federal Government |
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