Condition category
Pregnancy and Childbirth
Date applied
03/03/2019
Date assigned
25/04/2019
Last edited
29/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This is a new maneuver designed to improve the respiratory outcome of the newborns delivered by caesarian section. The idea is simple; the researcher suggests a maneuver through artificial compression of the chest of newborns delivered by caesarian section to simulate the squeezing effect of the normal vaginal delivery in order to evacuate the lung fluid as much as possible.

Who can participate?
Term and near term babies ( > 35 weeks gestational age)

What does the study involve?
This is a new maneuver designed to improve the respiratory outcome of the newborns delivered by caesarian section. It involves artificial compression of the chest of newborns delivered by caesarian section to simulate the squeezing effect of the normal vaginal delivery in order to evacuate the lung fluid as much as possible. The maneuver will be trialled on term and near term babies ( > 35 weeks gestational age) from the three participating centres throughout the study period.

What are the possible benefits and risks of participating?
The technique of this maneuver is important that it should be done with repetitive gentle compression of both sides of the chest; too little compression is of no benefit; whereas too much compression may cause fracture of the ribs and cardiac arrhythmias.

Where is the study run from?
1. Al-Batool Teaching Hospital, Mosul
2. Al-Khansa teaching hospital, Mosul
3. Nineveh private hospital, Mosul

When is the study starting and how long is it expected to run for?
February 2018 to December 2018

Who is funding the study?
Nenavah health office, Mosul, Iraq

Who is the main contact?
Dr Mohammed Hamid Al-sabawi
mhmmdalsabawi2@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Mohammed Hamid Al-sabawi

ORCID ID

http://orcid.org/0000-0001-6950-9444

Contact details

Ibn Sena Teaching Hospital
Mosul
41001
Iraq
+9647701607988
mhmmdalsabawi2@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A new maneuver for initial resuscitation of newborns after Caesarean delivery

Acronym

Study hypothesis

This study is designed to improve the respiratory outcome of the newborn delivered by caesarean section and to decrease the incidence and duration of transient tachypnea among these newborns due to wet lung syndrome.

Ethics approval

Not provided at time of registration

Study design

interventional case-control study

Primary study design

Interventional

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Transient tachypnea of newborns

Intervention

The researcher suggests a maneuver through gentle artificial compression of the chest of newborns delivered by caesarian section to simulate the squeezing effect of the normal vaginal delivery in order to evacuate the lung fluid as much as possible. This "Mohammed's maneuver" is done by upside-down position of the baby then gentle compression on the lateral sides of the chest of newborn for several times either by one or both hands of the obstetrician while the assistant is carrying the newborn or by carrying of the newborn by one hand of the obstetrician and compression of the chest by the other hand. It is preferably accompanied by suction of fluid from nose and mouth of newborn. This maneuver is safe and should not takes >30 seconds. The pressure of compression should be neither be too little or too severe.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Respiratory outcome of the newborns delivered by caesarian section measured using APGAR score assessed at 1, 5, 10, 15, and 20 min after birth.

Secondary outcome measures

The length of time the newborn displays transient tachypnea following birth.

Overall trial start date

01/01/2010

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Term and near term babies ( > 35 weeks gestational age)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Preterm (< 35 weeks gestation) neonates

Recruitment start date

01/02/2010

Recruitment end date

10/12/2018

Locations

Countries of recruitment

Iraq

Trial participating centre

Al-Batool Teaching Hospital (Gynaecology And Obstetrics)
Nenaveh
Mosul
14004
Iraq

Trial participating centre

Al-Khansa teaching hospital
Nenaveh
Mosul
14004
Iraq

Trial participating centre

Nineveh private hospital
Nenaveh
Mosul
14004
Iraq

Sponsor information

Organisation

Nineveh Health Directorate Training Center & Human Development

Sponsor details

Nineveh
Mosul
41001
Iraq
+9647701736208
mslhrtdc@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Nenavah health office

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed neonatal journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request and will be included in the subsequent results publication.

Intention to publish date

10/03/2019

Participant level data

Available on request

Basic results (scientific)

On studying of 500 babies (250 cases & 250 control) delivered by caesarian section. The 250 cases who undergo this new maneuver, majority of them (196) or (78.4%) have been received little or no further resuscitation (i.e. just the routine care e.g. suction and oxygen therapy); whereas the minority of cases (54) or (21.6%) required further resuscitation and interventions (e.g. ambu bag, nasal cannula/CPAP, endotracheal intubation and cardiac compression, or drugs e.g. adrenaline).
The 250 control who didn't undergo this maneuver, (123) or (49.2%) require little or no further resuscitation; whereas the other (127) or (50.8%) were require further resuscitation and interventions.
The duration of transient tachypnea also significantly decreased among most newborns cases from few to several hours in comparison with those controls that last longer.

Publication list

Publication citations

Additional files

Editorial Notes

29/04/2019: Contact details updated. 08/04/2019: Trial’s existence confirmed by Al-Batool hospital, Al-Khansa hospital, and Ninevah hospital.