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Status unknownNCT01477840Updated Dec 13, 2011

Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean

A Phase 2/3 interventional study of Misoprostol in Bleeding Intraoperative, sponsored by Soudabeh Eshghi ali. Status unknown at 1 site in Iran, Islamic Republic of. Open to female participants aged 15 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-13.

Sponsored by Soudabeh Eshghi ali · Phase 2/3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
180
Ages
15 Years to 44 Years
Sex
Female
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Study summary

The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.

Read the detailed description

A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.

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Conditions studied

  • Bleeding Intraoperative

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Keywords

  • Misoprostol
  • Oxytocin
  • Cesarean Delivery
  • Blood Loss
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 180 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Soudabeh Eshghi ali as lead sponsor.

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

04

Who can participate

Ages eligible
15 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Indication of Cesarean Deliveries
  • Elective or Emergency with Incision in Lower Segment in Women with
  • Gestational Age more than 37 Weeks.

Exclusion criteria

Exclusion Criteria:

  • Anemia
  • Multiple Pregnancy
  • Polyhydraminus
  • Prolonged Labor
  • Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
  • Hypertension
  • Cardiovascular Disease
  • Coagulopathy Disease
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Misoprostol

    Drug: Misoprostol

Interventions

  • DrugMisoprostol

    Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia

    Also known as: Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01

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What researchers measure

Primary outcomes

  1. Intraoperative bleeding

    Time frame: At the time of surgery

Secondary outcomes

  1. Fever

    Time frame: During 48 hours after surgery measured every 3 hours

  2. Changing of pulse rate from base

    Time frame: Before surgery & intraoperative & 6 hours after surgery

  3. Changing of blood pressure

    Time frame: Before surgery & intraoperative & 6 hours after surgery

  4. Diarrhea

    Time frame: Before & 6 hours after surgery

  5. Vomiting

    Time frame: Before & 6 hours after surgery

07

Study locations

1 site
  • KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
    Kermanshah, 67144-15333, Iran, Islamic Republic of
    • Anisodowleh Nankali, MD · Contact · anankali@kums.ac.ir · 98 831 4276310
    • Soudabeh Eshghi Ali, MD · Principal investigator
08

References and documents

Publications

  • Eftekhari N, Doroodian M, Lashkarizadeh R. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. J Obstet Gynaecol. 2009 Oct;29(7):633-6. doi: 10.1080/01443610903061744. PubMed 19757270 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01477840
Lead sponsor
Soudabeh Eshghi ali
Collaborators
Kermanshah University of Medical Sciences
Responsible party
Soudabeh Eshghi ali (Obstetrics & Gynecology Department, Kermanshah University of Medical Sciences) — Sponsor-investigator
First posted
Nov 23, 2011
Start date
Aug 2012
Primary completion
Aug 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Dec 13, 2011

Study contacts

Anisodowleh Nankali, MD
Contact
anankali@kums.ac.ir
98 831 4276310
Anisodowleh Nankali, MD
study chair · Kermanshah University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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