---
title: Prevention of Post-partum Haemorrhage
nct_id: NCT01044082
overall_status: COMPLETED
phase: NA
sponsor: Assistance Publique - Hôpitaux de Paris
study_type: INTERVENTIONAL
primary_condition: Postpartum Haemorrhage
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01044082.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01044082"
ct_last_update_post_date: 2026-02-13
last_seen_at: "2026-05-12T06:56:33.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Prevention of Post-partum Haemorrhage

**Official Title:** Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage

**NCT ID:** [NCT01044082](https://clinicaltrials.gov/study/NCT01044082)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 4382
- **Lead Sponsor:** Assistance Publique - Hôpitaux de Paris
- **Collaborators:** Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- **Conditions:** Postpartum Haemorrhage, Immediate Postpartum Hemorrhage
- **Start Date:** 2010-01
- **Completion Date:** 2012-03
- **CT.gov Last Update:** 2026-02-13

## Brief Summary

The primary purpose of the trial is to evaluate whether the management of placental delivery with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared with management waiting for clinical signs of spontaneous placental separation, in women with vaginal delivery receiving prophylactic oxytocin for the management of the third stage of labour.

The hypothesis is that CCT, by reducing the length of the third stage of labour, facilitates early postpartum uterine contraction and local haemostasis and decreases post partum blood loss.

## Detailed Description

In this randomized controlled trial, conducted in 6 maternity units, information will be provided to eligible women during a prenatal visit in late pregnancy. Once in labour ward, during labour and before delivery, and if eligible and willing to participate, the woman will be randomly allocated to the intervention or reference group.

In all women, immediately after the birth of the baby, 5 IU prophylactic oxytocin will be intravenously administered, the umbilical cord will be early clamped and cut, and a collector bag placed under the woman's buttocks.

In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.

In the reference group, clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure.

All other aspects of the management of the third stage will be standardized and common to all women.

On day 2 postpartum, a venous blood sample will be collected to measure plasma haemoglobin and haematocrit. On the same day, a questionnaire will be filled in by the woman to assess her satisfaction.

## Eligibility

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

```
Inclusion criteria :

* Age ≥ 18
* Expected vaginal delivery
* Gestational age ≥ 35 weeks
* Singleton pregnancy

Exclusion criteria :

* Age \<18
* Planned caesarean delivery
* Severe hemorrhagic disease
* Multiple Pregnancy
* Placenta praevia
* Intra uterine fetal death
* No health insurance coverage
```

## Arms

- **controlled cord traction** (EXPERIMENTAL) — Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.
- **clinical signs of placental separation** (ACTIVE_COMPARATOR) — Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure

## Interventions

- **controlled cord traction** (PROCEDURE) — In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs
- **Clinical signs of placental separation** (PROCEDURE) — Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure

## Primary Outcomes

- **Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL** _(time frame: immediately to two hours after delivery)_

## Secondary Outcomes

- **Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL** _(time frame: immediately to two hours after delivery)_
- **Measured postpartum blood loss at 30 minutes after delivery** _(time frame: at 30 minutes after delivery)_
- **Total measured postpartum blood loss** _(time frame: Time after delivery)_
- **Curative postpartum uterotonic treatment** _(time frame: Time after delivery)_
- **Postpartum transfusion** _(time frame: Time after delivery)_
- **Postpartum embolization or surgery for haemorrhage** _(time frame: Time after delivery)_
- **Peripartum haemoglobin delta** _(time frame: Time after delivery)_
- **Peripartum haematocrit delta** _(time frame: Time after delivery)_
- **Duration of third stage of labour** _(time frame: time before delivery)_
- **Deliveries with manual removal of placenta** _(time frame: 30 minutes)_
- **Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour** _(time frame: Time after delivery)_
- **Woman's satisfaction** _(time frame: two days after delivery)_

## Locations (1)

- Maternité de Port-Royal, Paris, France

## 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)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.maternité de port-royal|paris||france` — added _(2026-05-12)_

---

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