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Use of drugs to control blood pressue in mothers of babies having oxygen problems during the surgery of mother for birth of the baby.

A randomized trial comparing prophylactic phenylephrine vs ephedrine infusion during spinal anesthesia for cesarean delivery in case of fetal compromise.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/05/005777
Enrollment
94
Registered
2015-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- ASA I-II pregnant women aged 20-40 years taken up for emergency CD for acute fetal compromise under spinal anesthesia

Interventions

Intervention1: phenylephrine prepared in a 50ml syringe with concentration of 30µg/ml Rescue boluses were prepared similarly in identical 10 cc syringes to deliver P @ 50µg/ml: Baseline infusion was

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women undergoing emergency CD for acute fetal compromise under SA were recruited in this study.Acute fetal compromise included 1) non reassuring fetal heart rate (FHR): those cases which had a reassuring fetal heart status at the beginning of labor and later on showed Category 2 cardiotocograph trace with no improvement following intrauterine resuscitative measures. ref 2 Fetal growth restriction (FGR) requiring emergency cesarean delivery were included if the subject was near term pregnancy with fetal biophysical profile (BPP) > than 6 before induction of labour and later on showed category 2 trace. 3) Ante/intrapartum hemorrhage.

Exclusion criteria

Exclusion criteria: Patients who had contraindications for SA, cardiovascular or cerebrovascular diseases, congenital fetal abnormalities, diabetes mellitus, chronic hypertension, mild or severe preeclampsia, multiple gestation, gestational age < 28-34 weeks , growth restricted fetuses having chronic asphyxia (previous abnormal non stress test and BPP <6)

Design outcomes

Primary

MeasureTime frame
primary outcome of the study was to assess the incidence of fetal acidosis. Apgar score , need for immediate neonatal resuscitation, maternal hemodynamics and adverse effects, if any were the secondary outcomes assessed.Timepoint: From the double clamped segments of cord, heparinized samples were taken from umbilical artery and vein soon after delivery of the baby.

Secondary

MeasureTime frame
Apgar score, need for immediate neonatal resuscitation and maternal hemodynamicsTimepoint: During and after delivery

Countries

India

Contacts

Public ContactKAJAL JAIN

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA

kajalteji@gmail.com9814528468

Outcome results

None listed

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