Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

February 11, 2011 updated by: Erzincan Military Hospital

Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

In the aetiology of postpartum uterine atony, hypoxia is considered an important factor although some suggest that peripheral oxygen saturation is not influenced by oxygen inhalation in women during the first and second stages of labor. Enhancing oxygen delivery to myometrium through additional inhaled oxygen may improve uterine contractions. Therefore, it is reasonable to consider that oxygen inhalation may promote myometrial contraction and prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to relax in women encountering respiratory problems immediately after cesarean section under general anaesthesia further strengthened this theory.

The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen helps to maintain uterine retraction during immediate postpartum period and hence reduces vaginal blood loss.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Istanbul, Turkey
        • Recruiting
        • Bakirkoy Women's and Children's Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • gestational age between 37 and 42 weeks;
  • singleton pregnancy;
  • live fetus;
  • cephalic presentation;
  • neonatal birth weight of 2500-4500 g;
  • parity between one and five;
  • maternal age < 35 years old;
  • vaginal birth

Exclusion Criteria:

  • blood pressure ≥ 140/90mmHg;
  • placenta previa;
  • placental abruption;
  • a history of any bleeding during pregnancy;
  • a history of curettage;
  • cesarean section or any uterine scar;
  • a history of postpartum hemorrhage;
  • polyhydramnios;
  • signs or symptoms of maternal infection;
  • known uterine anomalies;
  • history of any drug use during labor;
  • abnormal placentation;
  • coagulation defects;
  • instrumental deliveries;
  • hemoglobin concentration < 8 g/dL;
  • history of anticoagulant drugs;
  • beta-mimetic medications during pregnancy;
  • prolongation of the first stage of labor > 15 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oxygen
either 8 L/minute O2 via face mask for 2 hours
Other Names:
  • Women were randomized to receive either 8 L/minute O2 via face mask for 2 hours or breathed room air at the end of second stage of labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was the amount of blood loss in the third and fourth stages of labor.
Time Frame: two hours
The volume of blood loss was measured by weighing a sheet soaked from the end of the delivery to 2h after birth. Because it is important to collect the blood accurately, we used a specially designed operating sheet and an electronic scale to weigh all the material (with a 1 g deviation range). The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05. Hemoglobin concentration was estimated on admission and 24 h after delivery
two hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidences of Postpartum Haemorrhage (PPH) (≥500 ml)
Time Frame: two hours
The volume of blood loss was measured by weighing a sheet soaked from the end of the delivery to 2h after birth. Because it is important to collect the blood accurately, we used a specially designed operating sheet and an electronic scale to weigh all the material (with a 1 g deviation range). The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05.
two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

February 14, 2011

Last Update Submitted That Met QC Criteria

February 11, 2011

Last Verified

May 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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