Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01180192
• Other study ID #: gungorduk09
• Status: Recruiting
• Phase: Phase 4
• First received: August 9, 2010
• Last updated: February 11, 2011
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2010
• Source: Erzincan Military Hospital
• Contact: osman asicioglu, M.D.
• Email: osmanasicioglu[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• oxygen
either 8 L/minute O2 via face mask for 2 hours

Locations

Country	Name	City	State
Turkey	Bakirkoy Women's and Children's Teaching Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two hours	Yes
Secondary	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.	two hours	Yes