NCT02083107

Brief Summary

The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
636

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 27, 2014

Completed
Last Updated

December 22, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

March 7, 2014

Results QC Date

April 24, 2014

Last Update Submit

November 22, 2015

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhageIntrapartum blood lossMisoprostol

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Blood Loss

    from start of cesarean section till the end of operation (average one hour)

Secondary Outcomes (7)

  • Need for Extra Ecbolics (Oxytocin).

    from start of cesarean section till the end of operation (average one hour)

  • APGAR Score

    1minute and 5 minutes from delivery of the fetus

  • Time to Resume Bowel Habits

    average 24 hours

  • Need for Extra Analgesics

    average 24 hours

  • Need for Postoperative Blood Transfusion

    average 24 hours

  • +2 more secondary outcomes

Other Outcomes (2)

  • Change in Hemoglobin Concentration

    24 hours postoperative from baseline hemoglobin

  • Change in Hematocrite Value

    24 hours postoperative from baseline hematocrite value

Study Arms (3)

sublingual misoprostol & rectal placebo

EXPERIMENTAL

will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

Drug: Misoprostol

rectal & sublingual placebo

PLACEBO COMPARATOR

will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".

Other: Placebo

rectal misoprostol & sublingual placebo

EXPERIMENTAL

will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".

Drug: Misoprostol

Interventions

MisoprostolDRUG

Comparison of different routes of administration of 400 micro gram misoprostol

Also known as: Misotac, Cytotec
rectal misoprostol & sublingual placebosublingual misoprostol & rectal placebo
PlaceboOTHER
rectal & sublingual placebo

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients booked for elective cesarean section.
  • Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section

You may not qualify if:

  • Primigravida.
  • 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.
  • Contraindication to spinal anesthesia.
  • Previous myomectomy.
  • Previous two or more C.S.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Mohamed S. Sweed, Dr.Mourad M.El-Said, Dr.Amgad E. Abou-Gamrah, Dr.Mohamed M. Abd-El-Hamid
Organization
AinShams University
drmsweed@gmail.com
01001222047

Study Officials

  • Mohamed S. Sweed, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Mourad M. El-Said, Professor

    AinShams University

    STUDY DIRECTOR

  • Amgad E. Abou-Gamrah, Ass.Prof.

    AinShams university

    STUDY DIRECTOR

  • Haitham El-Sabe, MD

    AinShams University

    STUDY DIRECTOR

  • Mohamed M. AbdEl-Hamid, Registrar

    AinShams University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohamed S. Sweed, Lecturer of Obstetrics &Gynecology, Ain Shams University

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

December 22, 2015

Results First Posted

June 27, 2014

Record last verified: 2015-11

Locations

EG(1)