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Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Erzincan Military Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01180192
First received: August 9, 2010
Last updated: February 11, 2011
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Postpartum Hemorrhage
 Drug: oxygen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Erzincan Military Hospital:

Primary Outcome Measures:
  • The primary outcome was the amount of blood loss in the third and fourth stages of labor. [ Time Frame: two hours ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • incidences of Postpartum Haemorrhage (PPH) (≥500 ml) [ Time Frame: two hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 450
Study Start Date: May 2010
Estimated Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxygen Drug: oxygen
either 8 L/minute O2 via face mask for 2 hours
Other Name: 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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180192

Contacts
Contact: osman asıcıoğlu, M.D. osmanasıcıoglu@gmail.com

Locations
Turkey
Bakirkoy Women's and Children's Teaching Hospital Recruiting
Istanbul, Turkey
Contact: Kemal Gungorduk, medical doctor     90 0505 492 17 66     maidenkemal@yahoo.com    
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

No publications provided

Responsible Party: Bakirkoy Women's and Children's Teaching Hospital, Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT01180192     History of Changes
Other Study ID Numbers: gungorduk09
Study First Received: August 9, 2010
Last Updated: February 11, 2011
Health Authority: Turkey: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Erzincan Military Hospital:
blood loss
oxygen inhalation

Additional relevant MeSH terms:
Postpartum Hemorrhage
Puerperal Disorders
Respiratory Aspiration
Hemorrhage
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Uterine Hemorrhage

ClinicalTrials.gov processed this record on May 19, 2013