Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives

Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial

Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.

Study Overview

• Status: Completed
• Conditions: Family Planning
• Intervention / Treatment: Device: Cell-phone

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who deliver a live birth at greater than 28 week's gestation.
• Women desire birth spacing for more than one year
• Women who were holding and /or one of her family hold a cell-phone and accept to receive messages and phone calls to remind her with her contraceptive program

Exclusion Criteria:

• Women who refuse to participate in the study.
• Women aren't able to respond to the questionnaire due to their health status.
• Anticipation of difficulty of subsequent communication with the women
• Women with contraindications of using long acting reversible contraception ( contraindicated if intrauterine device or implant use)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cell-phone assisted; will be advised that they are going to receive a reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits. They will be also provided with a cell phone number working 7 days a week to answer any query or questions regarding her family planning program.	Device: Cell-phone; a reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits.
No Intervention: control group; will receive the same above adequate counseling with referral card but without any phone assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Initiation of Long acting reversible contraception method	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
• Shaaban OM, Saber T, Youness E, Farouk M, Abbas AM. Effect of a mobile phone-assisted postpartum family planning service on the use of long-acting reversible contraception: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Aug;25(4):264-268. doi: 10.1080/13625187.2020.1764528. Epub 2020 May 21.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CP-LARC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No