Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

NCT01180192 | Unknown Phase 4

• 1 other identifier: gungorduk09
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Keywords

blood loss; oxygen inhalation

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the amount of blood loss in the third and fourth stages of labor.

  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 Outcomes (1)

• incidences of Postpartum Haemorrhage (PPH) (≥500 ml)

  two hours

Study Arms (1)

oxygen

EXPERIMENTAL

Drug: oxygen

Interventions

oxygen DRUG

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

Also known as: 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.

oxygen

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Bakirkoy Women's and Children's Teaching Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Central Study Contacts

osman asıcıoğlu, M.D.

CONTACT

osmanasıcıoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 12, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 14, 2011

Record last verified: 2010-05

Locations

TU (1)