Efficacy of the Standard Days Method of Family Planning

NCT00505609 | Completed

• 1 other identifier: SDM-IRH
• Study Type: interventional
• Target: 478
• Locations: 3 countries
• Sites: 3

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.

Conditions

Women's Health

Keywords

fertility awareness-based method; family planning; Standard Days Method; Institute for Reproductive Health; Efficacy; CycleBeads

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate with correct method use

  1 year (13 cycles)

Secondary Outcomes (1)

• Pregnancy rate with typical method use

  1 year (13 cycles)

Study Arms (1)

A

EXPERIMENTAL

The Institute for Reproductive Health trained health providers in teaching the Standard Days Method to study subjects and in study procedures. Providers counseled study participants in method use. Participants were followed for up to 13 cycles of method use.

Behavioral: Standard Days Method

Interventions

Standard Days Method BEHAVIORAL

The Standard Days Method is a fertility awareness-based method of family planning. Users avoid unprotected intercourse during cycle days 8 to 19. Study participants were for up to 13 cycles of method use.

Also known as: CycleBeads

A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Age 18-39
• Married or living with stable partner
• At least three cycles (four periods) since last birth
• Self reported cycles 26-32 days long
• Willing to avoid intercourse 12 consecutive days every cycle
• Partners willing to collaborate
• No known infertility problems
• Not at risk for sexually transmitted infections
• No contraindications of pregnancy
• No use of hormonal contraceptives in three months prior to admission
• Desiring to avoid pregnancy for at least one year

You may not qualify if:

• Women who have cycles outside of the 26-32 day range
• Women/couples not interested in the method
• Women who have not yet had 3 regular cycles after childbirth
• Women who have used hormonal contraceptives in the previous 3 months
• Those women at risk for sexual transmitted infections
• Women/couples who cannot manage the fertile days by avoiding intercourse or using a barrier method

Sponsors & Collaborators

• Georgetown University: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (3)

Institute for Reproductive Health, Bolivia

La Paz, Sopocachi, 243, Bolivia

Location

Instituto de Salud Reporductiva

Lima, La Molina, 1885, Peru

Location

Institute for Reproductive Health, Philippines

Quezon City, Loyola Heights, 1108, Philippines

Location

Related Publications (1)

• Arevalo M, Jennings V, Sinai I. Efficacy of a new method of family planning: the Standard Days Method. Contraception. 2002 May;65(5):333-8. doi: 10.1016/s0010-7824(02)00288-3.

  PMID: 12057784 RESULT

Study Officials

• Victoria H. Jennings, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: November 1, 1999
• Study Completion: October 1, 2001
• Last Updated: July 23, 2007

Record last verified: 2007-07

Locations

PE (1); PH (1); BO (1)