Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
Primary Purpose
Postpartum Hemorrhage
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring blood loss, oxygen inhalation
Eligibility 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
Sites / Locations
- Bakirkoy Women's and Children's Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
oxygen
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
incidences of Postpartum Haemorrhage (PPH) (≥500 ml)
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.
Full Information
NCT ID
NCT01180192
First Posted
August 9, 2010
Last Updated
February 11, 2011
Sponsor
Erzincan Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01180192
Brief Title
Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
Official Title
Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Erzincan Military Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
blood loss, oxygen inhalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oxygen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oxygen
Other Intervention Name(s)
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.
Intervention Description
either 8 L/minute O2 via face mask for 2 hours
Primary Outcome Measure Information:
Title
The primary outcome was the amount of blood loss in the third and fourth stages of labor.
Description
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
Time Frame
two hours
Secondary Outcome Measure Information:
Title
incidences of Postpartum Haemorrhage (PPH) (≥500 ml)
Description
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.
Time Frame
two hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
osman asıcıoğlu, M.D.
Email
osmanasıcıoglu@gmail.com
Facility Information:
Facility Name
Bakirkoy Women's and Children's Teaching Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kemal Gungorduk, medical doctor
Phone
90 0505 492 17 66
Email
maidenkemal@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
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