CompletedNot Applicable

Maternal Oxygen Administration for Fetal Distress II

China140 participantsStarted 2021-01-01

Plain-language summary

Supplementary oxygen is routinely administered to patients, even those with adequate oxygen saturations, in the belief that it increases oxygen delivery. However, oxygen delivery depends not just on arterial oxygen content but also on perfusion. Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. However, the effect of supplemental maternal oxygen therapy on fetal acid base status has been debated for more than seven decades. The investigators found the use of 2 L/min maternal oxygen during the second stage of labor did not adversely affect either the umbilical artery pH value or the fetal heart rate (FHR) pattern distribution.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: at term (\>37 weeks, \<42 weeks), singleton, cephalic presentation, spontaneous or induced labor, normal labor, category I FHR tracings, 2 to 3 cm of cervical dilation in nulliparity, 1 to 2 cm of cervical dilation in multipara, informed consent. Exclusion Criteria: respiratory or cardiovascular disease, diabetes mellitus or insulin-treated gestational diabetes mellitus, hypertension or preeclampsia, oligohydramnios, fetal growth restriction, placental abruption, cephalopelvic disproportion, meconium-stained amniotic fluid, tachysystole, having received O2, uterine incision (myomectomy or perforation), anemia, fever, chorioamnionitis, tobacco or alcohol use, disorders in oxygen saturations, hypotension, uncomfortable with facemask.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cord arterial pH values

Timeframe: within 30 to 60 seconds of birth

Cord arterial partial pressure of oxygen

Timeframe: within 30 to 60 seconds of birth

Cord arterial partial pressure of carbon dioxide

Timeframe: within 30 to 60 seconds of birth

Cord venous pH values

Timeframe: within 30 to 60 seconds of birth

Cord venous partial pressure of oxygen

Timeframe: within 30 to 60 seconds of birth

Cord venous partial pressure of carbon dioxide

Timeframe: within 30 to 60 seconds of birth

Trial details

NCT IDNCT03764696

SponsorNavy General Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-31

View on ClinicalTrials.gov More Oxygen Inhalation Therapy trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cord arterial pH values

Timeframe: within 30 to 60 seconds of birth

Cord arterial partial pressure of oxygen

Timeframe: within 30 to 60 seconds of birth

Cord arterial partial pressure of carbon dioxide

Timeframe: within 30 to 60 seconds of birth

Cord venous pH values

Timeframe: within 30 to 60 seconds of birth

Cord venous partial pressure of oxygen

Timeframe: within 30 to 60 seconds of birth

Cord venous partial pressure of carbon dioxide

Timeframe: within 30 to 60 seconds of birth