- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180192
Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: osman asıcıoğlu, M.D.
- Email: osmanasıcıoglu@gmail.com
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Bakirkoy Women's and Children's Teaching Hospital
-
Contact:
- Kemal Gungorduk, medical doctor
- Phone Number: 90 0505 492 17 66
- Email: maidenkemal@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oxygen
|
either 8 L/minute O2 via face mask for 2 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
two hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
two hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- gungorduk09
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