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CompletedNCT01931410Updated Feb 25, 2014

The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

A Phase 4 interventional study of Misoprostol in ıntrapartum Haemorrhage and Postpartum Haemorrhage, sponsored by Istanbul Bakirkoy Maternity and Children Diseases Hospital. Completed. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2014-02-25.

Sponsored by Istanbul Bakirkoy Maternity and Children Diseases Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
618
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • ıntrapartum Haemorrhage
  • Postpartum Haemorrhage
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 618 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. live and singleton pregnancy
  2. Elective caesarean
  3. Gestational week greater than 37 weeks
  4. patient between 18-44 year old

Exclusion criteria

Exclusion Criteria:

  1. -multiple pregnancy
  2. Preeclampsia
  3. Gestational diabetes
  4. Macrosomia
  5. Oligohidraamnıos
  6. Polihidraamnıos
  7. Myoma
  8. Morbid obesity
  9. Coagulatıon defect (such as HELLP syndrome)
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
618 participants (actual)

Study arms

  • Placebo comparator
    sublingual

    400 microgram mısoprostol will be administered sublıngually before elective caesarean

    Drug: Misoprostol

  • Placebo comparator
    rectal

    rectal 600 mgr misoprostol will be administered

    Drug: Misoprostol

  • No intervention
    synpitan

Interventions

  • DrugMisoprostol
06

What researchers measure

Primary outcomes

  1. Postpartum Haemorrhage

    Time frame: postpartum 24 hour

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01931410
Lead sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Responsible party
Osman Aşıcıoğlu (M.D. Obstetric and Gynecology, Istanbul Bakirkoy Maternity and Children Diseases Hospital) — Principal investigator
First posted
Aug 29, 2013
Start date
Jun 2013
Primary completion
Jan 2014
Completion
Feb 2014
Last update
Feb 25, 2014

Study contacts

Berhan AŞICIOĞLU, M.D.
principal investigator · T.C.S.B. Kanuni Sultan Süleyman Research Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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