NCT03135288

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

April 27, 2017

Last Update Submit

July 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Initiation of Long acting reversible contraception method

    6 months

Study Arms (2)

Cell-phone assisted

EXPERIMENTAL

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

control group

NO INTERVENTION

will receive the same above adequate counseling with referral card but without any phone assistance

Interventions

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.

Cell-phone assisted

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

Related Publications (2)

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 1, 2017

Study Start

July 1, 2017

Primary Completion

March 15, 2019

Study Completion

April 15, 2019

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations