---
title: Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
nct_id: NCT01630187
overall_status: COMPLETED
phase: PHASE4
sponsor: Laval University
study_type: INTERVENTIONAL
primary_condition: Uterine Atony
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01630187.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01630187"
ct_last_update_post_date: 2013-05-29
last_seen_at: "2026-05-12T07:26:17.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

**Official Title:** Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial

**NCT ID:** [NCT01630187](https://clinicaltrials.gov/study/NCT01630187)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** Laval University
- **Conditions:** Uterine Atony, Post-partum Hemorrhage
- **Start Date:** 2012-04
- **Completion Date:** 2012-07
- **CT.gov Last Update:** 2013-05-29

## Brief Summary

The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

## Detailed Description

Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* ≥ 18 years old
* ≥ 37-week pregnancy
* singleton pregnancy
* elective cesarean section with a low transverse incision
* ASA I or II

Exclusion Criteria:

* Personal history of uterine atony or postpartum hemorrhage
* Abnormal placental implantation (known or suspected)
* \> 3 cesarean sections in the past
* Personal history of a classic uterine incision
* Estimated fetal weight \> 4500g
* Hemoglobin \< 100 g/L
* Regular use of tocolytic drugs
* Cesarean section under general anesthesia
* Known allergy to carbetocin
* Refusal
* Inability to obtain informed consent
```

## Arms

- **Carbetocin 100 mcg** (ACTIVE_COMPARATOR)
- **Carbetocin 50 mcg** (EXPERIMENTAL)

## Interventions

- **Carbetocin** (DRUG) — Administration of carbetocin 50 mcg , after clamping the umbilical cord
- **Carbetocin** (DRUG) — Administration of carbetocin 100 mcg , after clamping the umbilical cord

## Primary Outcomes

- **Utilization of a second uterotonic drug** _(time frame: First 48 hours of the postpartum)_

## Secondary Outcomes

- **Incidence of side effects** _(time frame: During the fifteen minutes following the administration of carbetocin)_
- **Incidence of major complications** _(time frame: First 48 hours of the postpartum)_
- **Drop in hemoglobin measurement** _(time frame: on the second post-partum day)_

## Locations (1)

- Hôpital Saint-François-d'Assise (CHUQ), Québec, Quebec, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hôpital saint-françois-d'assise (chuq)|québec|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01630187.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01630187*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*