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
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
Public
Ibn Sena Teaching Hospital
Mosul
41001
Iraq
 ORCID ID |
0000-0001-6950-9444 |
|---|---|
| Phone | +9647701607988 |
| mhmmdalsabawi2@gmail.com |
Study information
| Study design | interventional case-control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available. |
| 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 | 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 study start date | 01/01/2010 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
Mosul
14004
Iraq
Mosul
14004
Iraq
Mosul
14004
Iraq
Sponsor information
Hospital/treatment centre
Nineveh
Mosul
41001
Iraq
| Phone | +9647701736208 |
|---|---|
| mslhrtdc@gmail.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 10/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed neonatal journal. |
| 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? |
|---|---|---|---|---|---|
| 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.
