NCT03239327

Brief Summary

Project summary: Objective: To test the hypothesis that administration of vaginal Misoprostol before elective cesarean section will improve the neonatal respiratory outcomes in late preterm and early term neonates through induction of catecholamine surge. Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two hundred and ninety two women will be randomly allocated to receive either 50 micrograms of Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or receive nothing (control group; n = 146) . Main outcome measure: Apgar score at 1 and 5 minutes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 8, 2018

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

July 30, 2017

Last Update Submit

January 4, 2018

Conditions

Neonatal Respiratory Distress

Keywords

Misoprostolneonatalrespiratory distresscesarean section

Outcome Measures

Primary Outcomes (1)

  • 1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.

    The number of neonates who need Neonatal Intensive Care Unit admission in each study group

    During the first 24 hours of life.

Study Arms (2)

study group

EXPERIMENTAL

For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS

Drug: Misoprostol

control group

NO INTERVENTION

For the control group mothers enrolled will receive nothing.

Interventions

MisoprostolDRUG
Also known as: Prostaglandin E1,Cytotec
study group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All pregnant women who are planned for elective (planned\& pre labor) cesarean section at 34 -37 weeks gestation.

You may not qualify if:

  • Pregnancies with known fetal malformation/s or chromosomal aberrations.
  • Presence of absolute contraindication for use of misoprostol.(i.e known hypersensitivity to the drug)
  • Women before 34 and after 37 weeks gestation .
  • Non reassuring cardiotocogram immediately before recruitment.
  • multiple pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

women health center,Assiut university

Asyut, Egypt

RECRUITING

Related Publications (4)

  • Motaze NV, Mbuagbaw L, Young T. Prostaglandins before caesarean section for preventing neonatal respiratory distress. Cochrane Database Syst Rev. 2013 Nov 11;2013(11):CD010087. doi: 10.1002/14651858.CD010087.pub2.

    PMID: 24218013BACKGROUND

  • Singh M, Patole S, Rane A, Naidoo D, Buettner P. Maternal intravaginal prostaglandin E2 gel before elective caesarean section at term to induce catecholamine surge in cord blood: randomised, placebo controlled study. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F131-5. doi: 10.1136/adc.2002.025957.

    PMID: 14977896BACKGROUND

  • Hansen AK, Wisborg K, Uldbjerg N, Henriksen TB. Risk of respiratory morbidity in term infants delivered by elective caesarean section: cohort study. BMJ. 2008 Jan 12;336(7635):85-7. doi: 10.1136/bmj.39405.539282.BE. Epub 2007 Dec 11.

    PMID: 18077440BACKGROUND

  • Yang JY, Fang LJ, Tsou Yau KI. Labor pain before elective cesarean section reduces neonatal respiratory distress. Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi. 1997 Jan-Feb;38(1):38-43.

    PMID: 9066188BACKGROUND

MeSH Terms

Conditions

Pulmonary AtelectasisDyspnea

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Ahmed Makhlouf, professor

    women health center,Assiut university,Assiut,Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Makhlouf, professor

CONTACT

0882414616amakhloufsalama@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor.Ahmed Mohammed Ahmed Makhlouf

Study Record Dates

First Submitted

July 30, 2017

First Posted

August 4, 2017

Study Start

June 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 8, 2018

Record last verified: 2017-08

Locations

EG(1)