Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oxygen

Group Type EXPERIMENTAL

oxygen

Intervention Type DRUG

either 8 L/minute O2 via face mask for 2 hours

Interventions

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oxygen

either 8 L/minute O2 via face mask for 2 hours

Intervention Type DRUG

Other Intervention Names

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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.

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes