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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03135288
Other study ID # CP-LARC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date April 15, 2019

Study information

Verified date July 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date April 15, 2019
Est. primary completion date March 15, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation of Long acting reversible contraception method 6 months
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