---
title: Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome
nct_id: NCT04816097
overall_status: UNKNOWN
phase: PHASE4
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: C08.381.840.500.475
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04816097.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04816097"
ct_last_update_post_date: 2021-03-26
last_seen_at: "2026-05-12T06:54:04.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome

**Official Title:** Role of Prophylactic Dexamethasone Administration Before Elective Cesarean Section at Term in Reducing the Incidence of Neonatal Respiratory Distress Syndrome (A Randomized Controlled Trial)

**NCT ID:** [NCT04816097](https://clinicaltrials.gov/study/NCT04816097)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 950
- **Lead Sponsor:** Ain Shams University
- **Conditions:** C08.381.840.500.475, C08.381.840.500.737
- **Start Date:** 2021-04-01
- **Completion Date:** 2022-04-01
- **CT.gov Last Update:** 2021-03-26

## Brief Summary

Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births.

assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and NICU admission as a result

## Detailed Description

Term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications The risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks If the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. Five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect According to Cochrane Database of Systematic Reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of RDS by approximately 52%. It also reduced the need for NICU admission, both due to respiratory morbidity (by approximately 58%) and for any indication. The reduction of NICU admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 35 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Gestational age (37-39wks).
* Singleton pregnancy.
* Didn't receive any steroid treatment during pregnancy.

Exclusion Criteria:

* Undetermined gestational age
* Maternal chronic diseases (e.g: hypertension, DM-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse.
* Congenital fetal malformations
* Emergency CS
* Pregnant refusing to participate in the study or unable to consent
```

## Arms

- **Steroid Group** (ACTIVE_COMPARATOR) — Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS.
- **No Steroid Group** (NO_INTERVENTION) — Participants will receive No treatment before elective CS.

## Interventions

- **Dexamethasone phosphate** (DRUG) — 4 doses of dexamethasone 6mg IM 48h before elective CS.

## Primary Outcomes

- **incidence of neonatal respiratory distress syndrome (RDS)** _(time frame: 1st 6 hours after delivery)_

## Secondary Outcomes

- **APGAR score** _(time frame: 1 min after delivery)_
- **APGAR score** _(time frame: 5 min after delivery)_
- **Rate of Neonatal intraventricular hemorrhage (IVH)** _(time frame: within 1st 48 hours after delivery)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04816097.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04816097*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*