Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304579281358 Date of Approval: 19/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does the use of antenatal corticosteroids reduce respiratory morbidity in babies born in late preterm period?
Official scientific title Does the use of antenatal corticosteroids reduce respiratory morbidity in babies born in late preterm period?
Brief summary describing the background and objectives of the trial Background: Late Preterm delivery is a common complication of pregnancy and has remained a major contributor to perinatal morbidity and mortality. However, few interventions have been undertaken to reduce the increased morbidity and mortality. Antenatal corticosteroid could be an effective preventive measure. Objective: The aim of this study is to determine the effectiveness of antenatal corticosteroid in reducing respiratory morbidity in babies born in the late preterm period. Patients and methods: Two hundred and eighty six pregnant women at risk of having a late preterm delivery were studied. One hundred and forty three(143) served as the cases and were given 2 doses of 12mg intramuscular dexamethasone 12 hours apart , while 143 served as the control and were given similar quantity of placebo. The women were followed up prospectively and data was collected on the pregnant women and their newborns on a standardized form. The neonates were assessed for acute respiratory distress syndrome and transient tachypnea of the newborn based on clinical signs, symptoms and Chest X-ray results (when indicated). The primary outcome was the occurrence of neonatal respiratory morbidity. Results: The primary outcome occurred in 5 out of 130 infants (3.8%) in the dexamethasone group and 31 out of 122 (25.4%) in the placebo group (P value=0.000003). Birth asphyxia, admission into the neonatal intensive care unit and need for active rescucitation at birth also occurred significantly less frequent in the dexamethasone group (P value 0.004, 0.009, 0.014 respectively). There were no significant group differences in the incidence of neonatal sepsis, neonatal jaundice, hypoglycemia and feeding difficulties. Conclusion: Administration of dexamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications. Keywords: Corticosteroids, Late preterm delivery, Respiratory morbidity,
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date 25/07/2019
Anticipated target sample size (number of participants) 286
Actual target sample size (number of participants) 286
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexamethasone 12mg x 2 doses 2 doses 12hours apart 2 doses of intramuscular dexamethasone was given to all participants in the intervention group 143
Control Group Placebo 3mls of 0.9% Saline solution 2 doses 12 hours apart 2 doses 0.9% saline solution 12 hours apart was given to all the participants in the control group. 143 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting pregnant women at the General Hospital Ifako Ijaye with gestational age between 34+0 and 36+6 weeks, who were at high risk of delivering before 37 weeks. A high probability of preterm delivery includes; Women with intact membranes and at least 3 cm dilation or 75% effacement of the cervix Spontaneous rupture of the membranes Expected preterm delivery for any other indication by induction of labour or caesarean section. All pregnant women with multiple pregnancy; Suspected or diagnosed major congenital malformations; Uncertain gestational age Clinical evidence of chorioamnionitis; Previous corticosteroid use during the antenatal period A woman who is expected to deliver in less than 12 hours. Women who were discharged from the hospital while still pregnant and who went on to deliver elsewhere were excluded from the study after randomization. New born: 0 Day-1 Month 0 Day(s) 28 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/01/2017 Health research and ethics committee LASUTH
Ethics Committee Address
Street address City Postal code Country
1-5,Oba Akinjobi way,Ikeja Lagos Lagos 100271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence of neonatal respiratory morbidity. These include: Respiratory distress syndrome; Transient tachypnea of the newborn and the need for ventilatory support within 72 hours of delivery with supplemental oxygen for at least 2 hours. Any neonate who had any of the 3 conditions is said to have had a respiratory morbidity. From birth to 28th day of life
Secondary Outcome These include: type of delivery; gestational age at birth; Apgar Scores at first and fifth minutes; admission to the Special Care Baby Unit (SCBU); neonatal hypoglycemia; neonatal jaundice; neonatal sepsis; other neonatal morbidities; length of stay at the hospital; neonatal death within 72 hours of delivery; the need for resuscitation at birth and feeding difficulties. from birth to 28th day of life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Ifako Ijaye Lagos Nigeria 14,College Road, Iju Road, Ifako. Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 69A,connaught road Bristol United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shittu khadijah 69A,connaught Road Bristol United Kingdom Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khadijah shittu talk2medo83@gmail.com 07861096906 69A,connaught Road
City Postal code Country Position/Affiliation
Bristol United Kingdom Royal United Hospital Bath
Role Name Email Phone Street address
Public Enquiries Kabiru Rabiu derabs@hotmail.com 08023036430 11,Afolabi Soberu street,Ebute Igbogbo Road
City Postal code Country Position/Affiliation
lagos Nigeria LASUTH IKEJA LAGOS
Role Name Email Phone Street address
Scientific Enquiries Saheed Ahmed esbeejay5@gmail.com 08086818283 10, Baba Olomi Junction, Agbala, ikorodu
City Postal code Country Position/Affiliation
Lagos Nigeria Damien Foundation Belgium
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial after deidentification Informed Consent Form,Study Protocol Beginning 9 months and ending 36 months following article publication. Researchers who provide a methodologically sound proposal. All the authors will decide. Request may be made by contacting the principal investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 05/04/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/04/2023 Result - 05/04/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/file/d/1FKiccafV0P0dVsYnpZ-2n6maOVSpwer-/view?usp=share_link
Changes to trial information