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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03135288

Collaborator

(none)

1,000

Enrollment

Location

Arms

21.5

Actual Duration (Months)

46.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Family Planning	Device: Cell-phone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Mar 15, 2019

Actual Study Completion Date :

Apr 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Initiation of Long acting reversible contraception method [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT03135288

Other Study ID Numbers:

CP-LARC

First Posted:

May 1, 2017

Last Update Posted:

Jul 19, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 19, 2019