NCT02221440

Brief 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. Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second stage of labor can relieve fetal distress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

August 16, 2014

Last Update Submit

May 21, 2020

Conditions

Oxygen Inhalation TherapySecond Stage of LabourFetal Distress

Outcome Measures

Primary Outcomes (1)

  • cord arterial pH values (hydrogen ion concentration) less than 7.2

    Immediately after delivery (within 30-60 seconds of birth), umbilical cord arterial blood gas sample will be obtained.

    within 30-60 seconds of birth

Secondary Outcomes (3)

  • Apgar score less than 7

    at one and five minutes after birth

  • maternal radial arterial partial pressure of oxygen

    within 30-60 seconds of birth

  • umbilical cord venous partial pressure of oxygen

    within 30-60 seconds of birth

Other Outcomes (7)

  • cesarean delivery rate

    during the second stage of labor

  • assisted vaginal delivery

    during the second stage of labor

  • maternal dissatisfaction

    during the second stage of labor

  • +4 more other outcomes

Study Arms (2)

air, second stage of labor

PLACEBO COMPARATOR

Patients randomized to the group will receive sham administered by nasal catheter. The therapy will continue until after delivery

Device: Low flow room air

oxygen, second stage of labor

EXPERIMENTAL

Patients randomized to the group will receive oxygen administered by low flow nasal oxygen at a flow rate of 2 L/min. The therapy will continue until after delivery

Device: Low flow nasal oxygen

Interventions

Low flow nasal oxygenDEVICE

Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery

oxygen, second stage of labor
Low flow room airDEVICE

Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.

air, second stage of labor

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • at term
  • singleton
  • primigraida
  • cephalic presentation
  • spontaneous or induced labor
  • normal labor
  • normal FHR tracings in the first stage
  • at the onset of second stage

You may not qualify if:

  • respiratory disease
  • cardiovascular disease
  • diabetes mellitus or insulin-treated gestational diabetes mellitus
  • hypertension or preeclampsia
  • oligohydramnios
  • fetal growth restriction
  • placental abruption
  • anemia
  • disorders in oxygen saturations
  • received oxygen therapy in the first stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Obstetrics and Gynecology, Navy General Hospital.

Beijing, Beijing Municipality, 100048, China

Location

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Department of Obstetrics and Gynecology, Navy General Hospital.

Beijing, 100048, China

Location

Related Publications (2)

  • Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.

    PMID: 28224745RESULT

  • Chuai Y, Jiang W, Xu X, Wang A, Yao Y, Chen L. Maternal oxygen exposure may not change umbilical cord venous partial pressure of oxygen: non-random, paired venous and arterial samples from a randomised controlled trial. BMC Pregnancy Childbirth. 2020 Sep 4;20(1):510. doi: 10.1186/s12884-020-03212-3.

    PMID: 32887557DERIVED

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yunhai Chuai, Dr

    Navy General Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Study Record Dates

First Submitted

August 16, 2014

First Posted

August 20, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 26, 2020

Record last verified: 2020-05

Locations

CN(3)