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The effect of rectal oxytocin suppositories compared to routine methods in reducing pain and bleeding after elective cesarean section

The effect of rectal oxytocin suppositories compared to routine methods in reducing pain and bleeding after elective cesarean section - a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221011056143N1
Enrollment
52
Registered
2022-10-16
Start date
2022-10-31
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Pain and bleeding after Cesaean Section. Other complications of obstetric surgery and procedures

Interventions

Intervention 1: Intervention group: In recovery, 10 units of intravenous oxytocin (per liter of serum) are injected and then rectal oxytocin suppositories are given. Suppositories contain 10 effective

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women candidates for elective cesarean surgery for the second time Age 20 to 40 years Full-term women (37 full weeks of pregnancy and singletons) who undergo active cesarean section for non-emergency reasons. A.S.A Class II Not suffering from underlying diseases such as diabetes, high blood pressure, preeclampsia, eclampsia or a history of taking certain drugs. Not suffering from hypothyroidism Insensitivity to oxytocin Absence of fetal anomalies No history of headache and migraine No history of taking psychotropic drugs No alcohol or drug addiction Complete mastery of official language conversation and the ability to read and write in Persian No meningitis at the time of study Not suffering from psychiatric diseases

Exclusion criteria

Exclusion criteria: Severe drop in blood pressure during cesarean section Any arrhythmia, whether tachyarrhythmia or bradyrhythmia Heavy bleeding during cesarean section Any disruption in the delivery process that prolongs the surgical process or repeats the caesarean section, including rupture of the bladder or bowels during surgery. Hemodynamic changes during surgery, nausea and vomiting, respiratory arrest, arrhythmia and severe bleeding The occurrence of shivering and severe pain in patients after surgery The need for extra days of oxytocin or the need for other drugs such as metrogen and misopropylol

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: 0.5, 1, 1.5, 3.5, 6 hours after surgery. Method of measurement: Visual analog scale questionnaire.;Bleeding. Timepoint: Within 24 hours after delivery. Method of measurement: Counting gasses and blood-soaked sheets to estimate the amount of bleeding.

Secondary

MeasureTime frame
Headache. Timepoint: 12, 24, 48 and 72 hours after surgery. Method of measurement: visual analog scale questionnaire.;Shivering. Timepoint: 20, 35, 50, 65, 80 and 95 minutes after surgery. Method of measurement: Crossley and Mahajan scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Zakikhani MD

Karaj University of Medical Sciences

mehdizakikhani??@gmail.com+98 26 3222 2021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026