NCT01931410

Brief Summary

The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
618

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

August 26, 2013

Last Update Submit

February 24, 2014

Conditions

ıntrapartum HaemorrhagePostpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

  • Postpartum Haemorrhage

    postpartum 24 hour

Study Arms (3)

sublingual

PLACEBO COMPARATOR

400 microgram mısoprostol will be administered sublıngually before elective caesarean

Drug: Misoprostol

rectal

PLACEBO COMPARATOR

rectal 600 mgr misoprostol will be administered

Drug: Misoprostol

synpitan

NO INTERVENTION

Interventions

MisoprostolDRUG
rectalsublingual

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • live and singleton pregnancy
  • Elective caesarean
  • Gestational week greater than 37 weeks
  • patient between 18-44 year old

You may not qualify if:

  • multiple pregnancy
  • Preeclampsia
  • Gestational diabetes
  • Macrosomia
  • Oligohidraamnıos
  • Polihidraamnıos
  • Myoma
  • Morbid obesity
  • Coagulatıon defect (such as HELLP syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Officials

  • Berhan AŞICIOĞLU, M.D.

    T.C.S.B. Kanuni Sultan Süleyman Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Obstetric and Gynecology

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 25, 2014

Record last verified: 2014-02