NCT07251569

Brief Summary

The goal of this clinical trial is to determine the effect of a mobile application developed for postpartum contraception counseling on contraception method choice and use among postpartum women aged 18 and older. The main hypotheses it aims to answer are;

  • H1: Among postpartum women, the use of highly effective contraceptive methods is higher in the group using a mobile application for contraception counseling compared to the group receiving face-to-face counseling.
  • H2: Among postpartum women, the use of highly effective contraceptive methods is higher in the group using a mobile application for contraception counseling compared to the group receiving routine postpartum care.
  • H3: Contraceptive method continuation and satisfaction are higher in the group using a mobile application for postpartum contraception counseling compared to the group receiving face-to-face counseling.
  • H4: Contraceptive method continuation and satisfaction are higher in the group using a mobile application for postpartum contraception counseling compared to the group receiving routine postpartum care. Researchers will compare three groups:
  • Group receiving contraception counseling via mobile app: Women in this group will have a postpartum contraception counseling mobile application installed on their phones and will use the application for 12 weeks.
  • Group receiving face-to-face contraception counseling: These women will receive face-to-face contraception counseling during the initial encounter, and an educational booklet will be provided at the end of the counseling session.
  • Control group: Women in this group will receive routine postpartum care. All groups will be followed up at three time points: the initial encounter, the first follow-up, and the second follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 19, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

contraceptionmobile application

Outcome Measures

Primary Outcomes (3)

  • Choice of contraceptive method and its effectiveness level

    The chosen contraceptive method and its effectiveness were categorically assessed using a "Client Information Form" at the first visit, a "Contraceptive Information Form II" at the first follow-up, and a "Follow-up Form" at the second follow-up. All three forms were developed by the researchers based on the relevant literature. The effectiveness of the contraceptive methods was determined according to the World Health Organization's estimates of unintended pregnancy rates during the first year of typical use. Methods with unintended pregnancy rates of less than 10% in the first year of typical use were classified as highly effective, whereas methods with rates of 10% or higher were classified as less effective.

    First Encounter (in the first 5 days postpartum) First Follow-Up (in the 6th week postpartum) Second Follow-Up (in the 12th week postpartum)

  • Level of satisfaction with the chosen contraceptive method

    Satisfaction with the chosen contraceptive method was measured numerically at the second follow-up using a question on the "Follow-up Form," scored from 1 to 10. A score of 1 means "I am not satisfied at all," and a score of 10 means "I am very satisfied." A higher score indicates higher satisfaction.

    Second Follow-Up (at the 12th postpartum week)

  • Status of continuing the chosen contraceptive method

    Continuity with the chosen contraceptive method was measured categorically at the second follow-up using the "Follow-up Form" developed by the researchers based on literature.

    Second Follow-Up (at the 12th postpartum week)

Secondary Outcomes (2)

  • Knowledge status regarding contraceptive methods

    First Encounter (in the first 5 days postpartum) First Follow-Up (in the 6th week postpartum) Second Follow-Up (in the 12th week postpartum)

  • Mobile Application Evaluation Form Results

    Second Follow-Up (in the 12th week postpartum)

Other Outcomes (1)

  • Assessment of Sociodemographic, Obstetric, and Gynecological Characteristics

    First Encounter (in the first 5 days postpartum)

Study Arms (3)

Control Group

OTHER

Participants received no intervention and only received routine hospital postpartum care.

Other: Routine postpartum care

Face-to-face counseling group

ACTIVE COMPARATOR

Participants received contraception counseling and an educational booklet.

Behavioral: Face-to-face contraception counseling

Mobile application counseling group

EXPERIMENTAL

Participants received contraceptive counseling through a mobile application developed as part of the study.

Behavioral: Contraceptive counseling via mobile application

Interventions

First Encounter: During the first five days postpartum, the postpartum woman was asked to complete the "Client Information Form" and "Contraceptive Information Form I." No intervention was performed. Postpartum women in this group received routine postpartum care offered to postpartum women in the hospital. First Follow-up: The client was called by phone at the sixth week postpartum. Breastfeeding status and whether she had initiated sexual intercourse were questioned. The "Contraceptive Information Form II" was completed by the researcher after being asked the client over the phone. Second Follow-up: The client was called again at the twelfth week postpartum. The "Follow-up Form" was completed by the researcher after being asked the client over the phone. At the end of the second follow-up, a general contraception counseling video was sent to the postpartum woman.

Control Group

First Encounter: During the first five days postpartum, the postpartum woman was asked to complete the "Client Information Form" and the "Contraceptive Information Form I." Sexuality during the postpartum period and the importance of contraception were then explained. Counseling on reproductive organ anatomy and general contraception was provided face-to-face, along with a booklet prepared as part of the research. At the end of the counseling, the booklet was given to the postpartum woman. She was told that she could review the booklet as often as she wished or needed. First Follow-Up: The client was contacted by phone at the sixth week postpartum. She was asked about her breastfeeding status and whether she had initiated sexual intercourse. The "Contraceptive Information Form II" was completed by the researcher over the phone. Second Follow-Up: The client was contacted again at the twelfth week postpartum. The "Follow-Up Form" was completed by the researcher over the phone.

Face-to-face counseling group

First Encounter: During the first five days postpartum, the postpartum woman was asked to complete the "Client Information Form" and "Contraceptive Information Form I." Information was provided about the importance of sexuality and contraception during the postpartum period. A postpartum contraception counseling mobile application was installed. The postpartum woman was asked to use the mobile application throughout the research period. First Follow-Up: The client was contacted by phone at the sixth week postpartum. She was asked about her mobile application use, breastfeeding status, and sexual intercourse status. The "Contraceptive Information Form II" was completed by phone. She was instructed to continue using the mobile application. Second Follow-Up: The client was contacted again at the twelfth week postpartum. She was asked about her mobile application use. The "Follow-Up Form" and "Mobile Application Evaluation Form" were completed by phone.

Mobile application counseling group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Being within the first 5 days postpartum
  • Having a healthy newborn
  • Not having received fertility treatment for the last pregnancy
  • Not having undergone tubal ligation during delivery
  • Owning a smartphone
  • Being able to use a mobile application
  • Having internet access
  • Being able to speak, read, and write in Turkish

You may not qualify if:

  • Having previously received contraceptive counseling
  • Discontinuing the use of the mobile application
  • Not participating in follow-up visits
  • Not volunteering to participate in the study
  • Having a diagnosed psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esenler Maternity and Child Diseases Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Berrami H, Serhier Z, Jallal M, Bennani Othmani M. Mobile Applications for Family Planning. Stud Health Technol Inform. 2023 Oct 20;309:300-301. doi: 10.3233/SHTI230803.

    PMID: 37869864BACKGROUND
  • Sze YY, Berendes S, Russel S, Bellam L, Smith C, Cameron S, Free CJ. A systematic review of randomised controlled trials of the effects of digital health interventions on postpartum contraception use. BMJ Sex Reprod Health. 2023 Jan;49(1):50-59. doi: 10.1136/bmjsrh-2022-201468. Epub 2022 Oct 28.

  • Cherie N, Wordofa MA, Debelew GT. Effectiveness of an Interactive Mobile Health Intervention (IMHI) to enhance the adoption of modern contraceptive methods during the early postpartum period among women in Northeast Ethiopia: A cluster Randomized Controlled Trial (RCT). PLoS One. 2024 Nov 14;19(11):e0310124. doi: 10.1371/journal.pone.0310124. eCollection 2024.

  • Dev R, Woods NF, Unger JA, Kinuthia J, Matemo D, Farid S, Begnel ER, Kohler P, Drake AL. Acceptability, feasibility and utility of a Mobile health family planning decision aid for postpartum women in Kenya. Reprod Health. 2019 Jul 8;16(1):97. doi: 10.1186/s12978-019-0767-9.

  • Sonalkar S, Maya E, Adanu R, Samba A, Mumuni K, McAllister A, Fishman J, Schurr D, Schreiber CA, Kolev S, Doe R, Eluned Gaffield M. Pilot monitoring and evaluation of the WHO postpartum family planning compendium mobile application: An in-depth, qualitative study. Int J Gynaecol Obstet. 2021 Jun;153(3):508-513. doi: 10.1002/ijgo.13631. Epub 2021 Mar 2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant, PhD Student, RN, MSc

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 26, 2025

Study Start

January 22, 2025

Primary Completion

August 27, 2025

Study Completion

August 27, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the absence of participant consent for external data sharing and institutional policies that restrict the release of raw data.

Locations