NCT03144401

Brief Summary

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 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
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 10, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

April 29, 2017

Last Update Submit

March 21, 2018

Conditions

Cesarean Section

Keywords

cesarean sectionMisoprostolsublingualuterotonics

Outcome Measures

Primary Outcomes (1)

  • Need for extra uterotonics

    24 hours

Secondary Outcomes (3)

  • intraoperative blood loss

    intraoperative

  • postpartum hemorrhage

    24 hours

  • neonatal outcome

    5 minutes

Study Arms (2)

Preoperative

ACTIVE COMPARATOR

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

Drug: MisoprostolOther: Placebo

Postoperative

ACTIVE COMPARATOR

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

Drug: MisoprostolOther: Placebo

Interventions

MisoprostolDRUG

mesotac

PostoperativePreoperative
PlaceboOTHER

Placebo tablet identical to the misoprostol tablet but without the active ingredient

PostoperativePreoperative

Eligibility Criteria

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

You may qualify if:

  • Patients booked for elective cesarean section.
  • Singleton pregnancies.
  • Full term pregnancies (GA 37- 42 Wks).
  • Age (18-40 yrs).
  • body mass index (BMI) (20-30(Kg/m2 .

You may not qualify if:

  • Contraindication to spinal anesthesia.
  • Blood dyscrasias.
  • Large fibroids.
  • Multiple pregnancies.
  • Overdistended uterus eg. Hydramnios.
  • Pre-eclampsia.
  • Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl).
  • Previous history of PPH.
  • Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
  • Placenta previa.
  • Previous myomectomy.
  • 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 8, 2017

Study Start

April 10, 2017

Primary Completion

January 12, 2018

Study Completion

February 1, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

EG(1)