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Preventive administration of vasopressor medication during cesarean section for fetal distress: an assessment of newborn outcome

Prophylactic Phenylephrine and Norepinephrine infusions during Caesarean Delivery for non-reassuring fetal heart rate: A randomised non-inferiority trial to assess neonatal outcome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039343
Enrollment
106
Registered
2022-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O68- Labor and delivery complicated byabnormality of fetal acid-base balance

Interventions

Intervention1: vasopressor infusion and/or boluses of norepinephrine and phenylephrine: According to the randomization code, the anesthesiologist will prepare a solution of either norepinephrine 6μg/

Sponsors

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status II. 2. Women with category I fetal heart trace at the beginning of labor and later on showed a change to category II trace with/without improvement following intrauterine fetal resuscitation (IUFR). 3. Fetal growth restriction (FGR) requiring emergency CD was included if the subject was near-term pregnancy with fetal biophysical profile more than 6 before induction of labor and later on showed category II trace with normal fetal doppler flows. 4. Women with Category II FHR tracings

Exclusion criteria

Exclusion criteria: 1. Refusal to give informed consent. 2. Age 3. Allergy to phenylephrine and norepinephrine. 4. Contraindication for SA. 5. Known fetal abnormality. 6. Cardiovascular or cerebrovascular diseases. 7. Any autoimmune disorder. 8. Hypertensive disorder of pregnancy. 9. Diabetes mellitus. 10. Multiple gestation. 11. Growth restricted fetus having chronic asphyxia (previous abnormal nonstress test and biophysical profile less than 6). 12. Ruptured membranes with meconium-stained liquor, or evidence of intrauterine infection.

Design outcomes

Primary

MeasureTime frame
Comparison of UA base excess in phenylephrine and norepinephrine group. Timepoint: 1 year—

Secondary

MeasureTime frame
1. UA blood gas parameters (pH, PaO2, PaCO2, lactate) 2. APGAR score at 1min and 5min 3. Newborn requiring immediate resuscitation measures 4. Incidence of maternal hypotension and bradycardia 5. Intraoperative nausea, vomiting (IONV) Timepoint: 1 year;1. UA blood gas parameters (pH, PaO2, PaCO2, lactate) 2. APGAR score at 1min and 5min 3. Newborn requiring immediate resuscitation measures 4. Incidence of maternal hypotension and bradycardia 5. Intraoperative nausea, vomiting (IONV) Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Heena Sharma

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH

nitikagoel7@gmail.com8826622159

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026