Postpartum HemorrhagePhase 4NCT01180192
Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
A Phase 4 study testing oxygen in people with Postpartum Hemorrhage, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2010to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
osman asıcıoğlu, M.D. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Women's and Children's Teaching Hospital
Istanbul
Kemal Gungorduk, medical doctor, 90 0505 492 17 66, maidenkemal@yahoo.com
About this study
Official title: 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- oxygen
- Keywords
- blood loss, oxygen inhalation
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenDrug
Also called 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.
either 8 L/minute O2 via face mask for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| oxygen | Experimental | Not described Receives: Drug: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two hours
Secondary outcomes (1)
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.
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2010
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180192
- Sponsor's protocol ID
- gungorduk09
- Status last verified
- May 2010
- First submitted
- 9 Aug 2010
- Last updated
- 14 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
- ClinicalTrials.gov ID
- NCT01180192
- Acronym / sponsor ID
- gungorduk09
- Conditions
- Postpartum Hemorrhage
- Keywords
- blood loss, oxygen inhalation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (estimated)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oxygen | Experimental | Drug: oxygen |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- gestational age between 37 and 42 weeks;
- singleton pregnancy;
- live fetus;
- cephalic presentation;
- neonatal birth weight of 2500-4500 g;
Key exclusion criteria (18 listed)
- blood pressure ≥ 140/90mmHg;
- placenta previa;
- placental abruption;
- a history of any bleeding during pregnancy;
- a history of curettage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygenAlso: 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.either 8 L/minute O2 via face mask for 2 hours | Drug | oxygen |
Primary outcome
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
1 secondary outcome
incidences of Postpartum Haemorrhage (PPH) (≥500 ml)
Time frame: two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
osman asıcıoğlu, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxygen in people with Postpartum Hemorrhage, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact osman asıcıoğlu, M.D. (osmanasıcıoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the amount of blood loss in the third and fourth stages of labor. (time frame: two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011.