Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505609
Status:
COMPLETED
Last Update Posted:
2007-07-23
First Post:
2007-07-20
Brief Title:
Efficacy of the Standard Days Method of Family Planning
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Efficacy of the Standard Days Method of Family Planning
Status:
COMPLETED
Status Verified Date:
2007-07
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:
The Standard Days Method is a fertility awareness-based method of family planning in which users avoid unprotected intercourse during cycle day 8 through 19 The method is most appropriate for women with cycles that usually range 26-32 days The clinical trial tested the contraceptive efficacy of the Standard Days Method A total of 478 women age 18-39 years in Bolivia Peru and the Philippines with self-reported cycles of 26-32 days desiring to delay pregnancy at least one year were admitted to the study and followed for up to 13 cycles of method use
Detailed Description:
The Standard Days Method is a fertility awareness-based method of family planning Users avoid unprotected intercourse during cycle day 8 through cycle day 19 The method is most effective for women with cycles that usually range 26-32 days It was developed by applying various formulae ie various numbers of days and various sets of days to over 7500 menstrual cycles in an existing data set from the World Health Organization to determine which formula would provide the optimal balance between he length of the identified fertile period and the efficacy in avoiding unplanned pregnancy
The purpose of the clinical trial was to test the efficacy of the method in preventing pregnancy
Participants were from five sites in Bolivia Peru and the Philippines In all sites the Institute for Reproductive Health trained 5-10 health workers service providers in teaching the Standard Days Method to study subjects and in study procedures Method provision involved a counseling session in which the woman or the couple if her partner was available was instructed in the use of the method and counseled on the importance of following the method recommendations to avoid pregnancy
To assist women in monitoring their cycles the provider gave them CycleBeads a mnemonic device a string of 32 beads in which each beads represents a day of the menstrual cycle The first bead is red representing the first day of menses the next 6 beads are brown representing the additional non-fertile days preceding the fertile window the next 12 beads are white representing days that should be considered fertile 8-19 and the remaining 13 beads are brown again representing non-fertile days It also has a moveable tight-fitting rubber ring that is used to mark the current day of the cycle Women were instructed to place the ring on the red bead on the day their menses began and move the ring one bead per day until their menses returned They also were told that to avoid pregnancy they should not have unprotected intercourse on the days the ring was on a white bead If they had menstrual bleeding before day 27 of the cycle ie a cycle shorter than 26 days or if their menses had not occurred by the day after they completed all 32 beads ie a cycle longer than 32 days they were instructed to contact their provider for further assessment and advice Women who had two cycles outside the 26 through 32 day range during the study period were advised to use another method and were withdrawn from the study
A total of 478 women wishing to use the Standard Days Method and meeting the eligibility criteria were admitted to the study after signing an informed consent form and interviewed monthly until they either completed 13 cycles of method use or left the study for other reasons The first level of data collection was administered by the clients themselves Each woman was asked to keep a daily diary to record menstrual bleeding intercourse and use of any other contraceptive method The information on the diary card was reviewed by the clients and the service provider during each of the monthly follow-up contacts In addition follow-up forms were administered which included questions concerning method use satisfaction and willingness to continue in the study
Women who had not had their menses by day 42 of their cycle were tested for pregnancy If results were negative they were followed until they tested positive or their menses returned Loss to follow-up was minimized by interviewing study participants in their homes and actively seeking out each participant with a minimum of three attempts per cycle
Single-decrement multi-censoring life tables were used to calculate pregnancy rates
The purpose of the clinical trial was to test the efficacy of the method in preventing pregnancy
Participants were from five sites in Bolivia Peru and the Philippines In all sites the Institute for Reproductive Health trained 5-10 health workers service providers in teaching the Standard Days Method to study subjects and in study procedures Method provision involved a counseling session in which the woman or the couple if her partner was available was instructed in the use of the method and counseled on the importance of following the method recommendations to avoid pregnancy
To assist women in monitoring their cycles the provider gave them CycleBeads a mnemonic device a string of 32 beads in which each beads represents a day of the menstrual cycle The first bead is red representing the first day of menses the next 6 beads are brown representing the additional non-fertile days preceding the fertile window the next 12 beads are white representing days that should be considered fertile 8-19 and the remaining 13 beads are brown again representing non-fertile days It also has a moveable tight-fitting rubber ring that is used to mark the current day of the cycle Women were instructed to place the ring on the red bead on the day their menses began and move the ring one bead per day until their menses returned They also were told that to avoid pregnancy they should not have unprotected intercourse on the days the ring was on a white bead If they had menstrual bleeding before day 27 of the cycle ie a cycle shorter than 26 days or if their menses had not occurred by the day after they completed all 32 beads ie a cycle longer than 32 days they were instructed to contact their provider for further assessment and advice Women who had two cycles outside the 26 through 32 day range during the study period were advised to use another method and were withdrawn from the study
A total of 478 women wishing to use the Standard Days Method and meeting the eligibility criteria were admitted to the study after signing an informed consent form and interviewed monthly until they either completed 13 cycles of method use or left the study for other reasons The first level of data collection was administered by the clients themselves Each woman was asked to keep a daily diary to record menstrual bleeding intercourse and use of any other contraceptive method The information on the diary card was reviewed by the clients and the service provider during each of the monthly follow-up contacts In addition follow-up forms were administered which included questions concerning method use satisfaction and willingness to continue in the study
Women who had not had their menses by day 42 of their cycle were tested for pregnancy If results were negative they were followed until they tested positive or their menses returned Loss to follow-up was minimized by interviewing study participants in their homes and actively seeking out each participant with a minimum of three attempts per cycle
Single-decrement multi-censoring life tables were used to calculate 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