NCT02901639

Brief Summary

Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy also is a major health problem in the United States of America. In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

September 10, 2016

Last Update Submit

June 26, 2018

Conditions

Improving Quality of Life

Outcome Measures

Primary Outcomes (1)

  • The difference in the rate of unintended pregnancy in both groups

    6 months

Study Arms (2)

counseling group

EXPERIMENTAL

will receive counseling about contraceptive methods using illustrations through postpartum interview with the study

Other: counseling

NO counseling

NO INTERVENTION

will not receive any counseling about contraceptive methods

Interventions

counselingOTHER
counseling group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: above 18 years
  • Primigravida
  • Women who will accept to participate in

You may not qualify if:

  • Women who are not intended to use contraception
  • Multiparous
  • Women who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

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

September 10, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

EG(1)