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

Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477840

Enrollment

180

Registered

2011-11-23

Start date

2012-08-31

Completion date

2012-08-31

Last updated

2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Intraoperative

Keywords

Misoprostol, Oxytocin, Cesarean Delivery, Blood Loss

Brief 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.

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.

Interventions

DRUGMisoprostol

Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia

Study design

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 44 Years

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

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

Design outcomes

Primary

Measure	Time frame
Intraoperative bleeding	At the time of surgery

Secondary

Measure	Time frame
Changing of blood pressure	Before surgery & intraoperative & 6 hours after surgery
Diarrhea	Before & 6 hours after surgery
Fever	During 48 hours after surgery measured every 3 hours
Changing of pulse rate from base	Before surgery & intraoperative & 6 hours after surgery
Vomiting	Before & 6 hours after surgery

Countries

Iran

Contacts

Primary ContactAnisodowleh Nankali, MD

anankali@kums.ac.ir98 831 4276310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026