Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068848
Status:
COMPLETED
Last Update Posted:
2007-04-10
First Post:
2003-09-10
Brief Title:
Quick Start Approach to Birth Control Pills
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
RCT of a Novel Oral Contraceptive Initiation Method
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 doctors office rather than waiting until the next menstrual cycle
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None