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

Not Applicable

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

• Registration Number: CTRI/2022/01/039343
• Lead Sponsor: POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

1. Refusal to give informed consent.

2. Age <18yrs.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of UA base excess in phenylephrine and norepinephrine group. <br/ ><br>Timepoint: 1 year

Secondary Outcome Measures

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