Can gentle pressing of the chest of newborns delivered by Caesarean section simulate the squeezing of fluid from the baby’s lungs during vaginal delivery and improve the baby’s breathing in the hours after birth?

ISRCTN	ISRCTN52035970
DOI	https://doi.org/10.1186/ISRCTN52035970
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Nineveh Health Directorate Training Center & Human Development
Funder	Nenavah health office

Submission date: 03/03/2019
Registration date: 25/04/2019
Last edited: 23/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mohammed Hamid Al-sabawi
Public

Ibn Sena Teaching Hospital
Mosul
41001
Iraq

ORCID ID	0000-0001-6950-9444
Phone	+9647701607988
Email	mhmmdalsabawi2@gmail.com

Study information

Primary study design	Interventional
Study design	interventional case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	A new maneuver for initial resuscitation of newborns after Caesarean delivery
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Respiratory outcome of the newborns delivered by caesarian section measured using APGAR score assessed at 1, 5, 10, 15, and 20 min after birth.
Key secondary outcome measure(s)	The length of time the newborn displays transient tachypnea following birth.
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Term and near term babies ( > 35 weeks gestational age)
Key exclusion criteria	1. Preterm (< 35 weeks gestation) neonates
Date of first enrolment	01/02/2010
Date of final enrolment	10/12/2018

Locations

Countries of recruitment

Iraq

Study participating centres

Al-Batool Teaching Hospital (Gynaecology And Obstetrics)

Nenaveh
Mosul
14004
Iraq

Al-Khansa teaching hospital

Nenaveh
Mosul
14004
Iraq

Nineveh private hospital

Nenaveh
Mosul
14004
Iraq

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/11/2020	23/03/2023	Yes	No
Basic results		12/12/2019	12/12/2019	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN52035970_BasicResults_12Dec19.pdf: Uploaded 12/12/2019.

Editorial Notes

23/03/2023: Publication reference added.
12/12/2019: The basic results of this trial have been uploaded as an additional file.
29/08/2019: Internal review.
29/04/2019: Contact details updated.
08/04/2019: Trial’s existence confirmed by Al-Batool hospital, Al-Khansa hospital, and Ninevah hospital.