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

Study information

Study designinterventional case-control study
Primary study designInterventional
Secondary study designCase-control study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available.
Scientific titleA new maneuver for initial resuscitation of newborns after Caesarean delivery
Study objectivesThis 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) studiedTransient tachypnea of newborns
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureRespiratory 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 measuresThe length of time the newborn displays transient tachypnea following birth.
Overall study start date01/01/2010
Completion date31/12/2018

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants500
Key inclusion criteria1. Term and near term babies ( > 35 weeks gestational age)
Key exclusion criteria1. Preterm (< 35 weeks gestation) neonates
Date of first enrolment01/02/2010
Date of final enrolment10/12/2018

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

Sponsor information

Nineveh Health Directorate Training Center & Human Development
Hospital/treatment centre

Nineveh
Mosul
41001
Iraq

Phone +9647701736208
Email mslhrtdc@gmail.com

Funders

Funder type

Hospital/treatment centre

Nenavah health office

No information available

Results and Publications

Intention to publish date10/03/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed neonatal journal.
IPD sharing planThe 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?
Basic results 12/12/2019 12/12/2019 No No
Results article 11/11/2020 23/03/2023 Yes No

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.