Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
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|ClinicalTrials.gov Identifier: NCT01180192|
Recruitment Status : Unknown
Verified May 2010 by Erzincan Military Hospital.
Recruitment status was: Recruiting
First Posted : August 12, 2010
Last Update Posted : February 14, 2011
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 or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: oxygen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||September 2010|
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.
- 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
- 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.
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
|Contact: osman asıcıoğlu, M.D.||osmanasıcıoglu@gmail.com|
|Bakirkoy Women's and Children's Teaching Hospital||Recruiting|
|Contact: Kemal Gungorduk, medical doctor 90 0505 492 17 66 firstname.lastname@example.org|