NCT03148717

Brief Summary

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol. 2017\. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2017

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

April 29, 2017

Last Update Submit

March 21, 2018

Conditions

Neonatal Outcome

Outcome Measures

Primary Outcomes (1)

  • Neonatal outcome

    measured by APGAR score at 5 minutes

    5 minutes

Secondary Outcomes (4)

  • NICU admission

    24 hours

  • amount of blood loss

    24 hours

  • Postpartum hemorrhage

    24 hours

  • Need for extra uterotonics

    24 hours

Other Outcomes (1)

  • APGAR score at 1 minute

    1 minute

Study Arms (2)

Preoperative

ACTIVE COMPARATOR

Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".

Drug: MisoprostolOther: Placebo

Postoperative

ACTIVE COMPARATOR

Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .

Drug: MisoprostolOther: Placebo

Interventions

MisoprostolDRUG

Cytotec

Also known as: Mesotac
PostoperativePreoperative
PlaceboOTHER

Placebo tablet similar in shape, odour and consistency to misoprostol tablet.

PostoperativePreoperative

Eligibility Criteria

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

You may qualify if:

  • Patients candidate for cesarean section.
  • Full term pregnancies (GA 37- 42 Wks).
  • Age (18-40 yrs).
  • body mass index (BMI) (20-30(Kg/m2 .
  • Contraindication to spinal anesthesia.
  • Blood dyscrasias.
  • Large fibroids.
  • Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
  • Emergency CS such as fetal distress
  • Extreme of BMI (\<20 or \>30 Kg/m2 ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2017

First Posted

May 11, 2017

Study Start

May 10, 2017

Primary Completion

March 2, 2018

Study Completion

March 20, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

EG(1)