NCT02785094

Brief Summary

This study focus on measuring effect of Egyptian Primigravidas' education level and accessibility to social media on rate of maternal request option offered for non-indicated primary caesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

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

May 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

May 23, 2016

Last Update Submit

September 2, 2016

Conditions

Complications; Cesarean Section

Keywords

Caesarean Section RatePrimigravida

Outcome Measures

Primary Outcomes (1)

  • Number of Primigravidas who request a Non-Indicated CS

    Number of Primigravidas who request a Non-Indicated CS.

    Up to 2 weeks

Secondary Outcomes (1)

  • Number of Primigravidas who refused to have a trial of IOL (Induction of Labour), as an index for deviated intention to request a Non-Indicated CS

    Up to 24 hours

Study Arms (4)

A

Group of High Education level

Behavioral: Observation

B

Group of Low/Non Education level

Behavioral: Observation

C

Group has Accessibility to Social Media

Behavioral: Observation

D

Group has not Accessibility to Social Media

Behavioral: Observation

Interventions

ObservationBEHAVIORAL

Observation of Participants' behaviour

ABCD

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primigravidas whom been carefully counselled, and the overall risks and benefits of caesarean section and vaginal birth, and IOL for prolonged pregnancy discussed with.

You may qualify if:

  • Full term with gestational age (G.A) more than or equal 39 weeks.
  • Acceptance to answer study short questionnaire to determine eligible participants for each cohort.

You may not qualify if:

  • Multiparity.
  • History of previous Caesarean Section/s.
  • Any Mental or Physical disabilities.
  • Disapproval for answering a predefined short questionnaire related to study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Talkha Central Hospital

Al Mansurah, Al-Dakahliya, 35511, Egypt

Location

Related Publications (4)

  • Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.

    PMID: 26849801BACKGROUND

  • Gibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.

    BACKGROUND

  • Ministry of Health and Population [Egypt], El-Zanaty and Associates [Egypt], and ICF International. 2015. Egypt Demographic and Health Survey 2014. Cairo, Egypt and Rockville, Maryland, USA: Ministry of Health and Population and ICF International.

    BACKGROUND

  • Thomas J, Paranjothy S. Royal College of Obstetricians and Gynaecologists Clinical Effectiveness Support Unit. National Sentinel Caesarean Section Audit Report. London: RCOG press; 2001.

    BACKGROUND

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Amro M Hetta, M.B., Ch.B.

    Talkha Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Amro M. Hetta

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 27, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

EG(1)