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Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Erzincan Military Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180192
First Posted: August 12, 2010
Last Update Posted: February 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Erzincan Military Hospital
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]
    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 ]
    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

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 9, 2010
First Posted: August 12, 2010
Last Update Posted: February 14, 2011
Last Verified: May 2010

Keywords provided by Erzincan Military Hospital:
blood loss
oxygen inhalation

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