NCT05355636

Brief Summary

Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility. According to the Turkey Demographic and Health Survey 2018 data, 70% of women in Turkey who are currently married do not use any contraceptive method. Based on the same data, the rate of the unmet need for fertility management is 12% nationwide, 14% in eastern provinces, and 17% in women at the ages of 20-24. These rates show that the rates of unmet fertility management needs in Turkey are still not on the desired level. The fact that eastern provinces of Turkey have the lowest rate of modern contraceptive method use as 43% and a high rate of unmet fertility management needs as 14% suggests that it is needed to increase the effectiveness of fertility management counseling and reach more women. In these eastern provinces, especially women living in rural areas do not have easy access to these services due to the high prevalence of adolescent marriages, lack of transportation opportunities, healthcare personnel and healthcare services, and unpredictable weather conditions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 2, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 14, 2022

Last Update Submit

April 27, 2022

Conditions

Keywords

fertility managementcounseling

Outcome Measures

Primary Outcomes (2)

  • Telehealth on Contraceptive Use

    The use of birth control methods by the fertility regulation consultancy service offered by Telehealth in postpartum women is a positive indicator of counseling.

    7 months

  • Family Planning Method Using Status Form

    It is a scale that examines the method use status of the participants after telehealth assisted fertility regulation counseling.

    7 months

Study Arms (2)

experiment group

EXPERIMENTAL

patient receiving counseling

Behavioral: Fertility Management Counseling

control group

NO INTERVENTION

patient without counseling

Interventions

counseling

experiment group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between the ages of 18-45 who gave birth in primiparous
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • volunteer
  • be between the ages of 18-45
  • to be primiparous
  • have a smart phone
  • complete education

You may not qualify if:

  • refuse to research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duygu Tatar

Bitlis, Bi̇tli̇s, 13000, Turkey (Türkiye)

Location

Study Officials

  • duygu tatar, MsC Student

    Marmara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meltem Demirgöz BAL, prof.

CONTACT

duygu tatar, MsC Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

May 2, 2022

Study Start

May 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

May 2, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations