ISRCTN ISRCTN12216455
DOI https://doi.org/10.1186/ISRCTN12216455
Secondary identifying numbers 262820
Submission date
27/02/2019
Registration date
01/03/2019
Last edited
29/03/2021
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
Pregnancies with big babies are associated with maternal complications, such as emergency caesarean section, post-partum hemorrhage (heavy bleeding after delivery) and perineal trauma and neonatal complications, including shoulder dystocia, brachial plexus injury (OBPI), fracture of humerus or clavicle and birth asphyxia. Despite the association of big babies with pregnancy complications as well as its relatively common occurrence in clinical practice, there is lack of a clear consensus regarding management of pregnancies with big babies with no guidance from professional bodies on either the identification, diagnosis nor management of when there is a diagnosis of a big baby during the pregnancy. The aims of our study are firstly, to compare the prevalence of pregnancy complications in pregnancies with big babies compared to those that are not; secondly, to determine whether complications in pregnancies with big babies can be predicted effectively from maternal and pregnancy characteristics and thirdly, in pregnancies that are deemed to be high risk, we aim to assess whether delivery at an earlier gestation is associated with a reduction in the incidence of adverse outcomes.

Who can participate?
Health records from singleton pregnancies with healthy babies from the last 8-9 years will be analysed.

What does the study involve?
The study is retrospectively analysing health records.

What are the possible benefits and risks of participating?
Not applicable

Where is the study run from?
Medway NHS Foundation Trust, Fetal Medicine Unit, Gillingham, Kent, ME7 5NY

When is the study starting and how long is it expected to run for?
January 2009 to March 2019

Who is funding the study?
Health Education England, Kent Surrey and Sussex

Who is the main contact?
Professor RanjitAkolekar, ranjit.akolekar@canterbury.ac.uk

Contact information

Prof Ranjit Akolekar
Scientific

Institute of Medical Sciences
Canterbury Christ Church University
Rowan Williams Court
30, Pembroke Court
Chatham
ME4 4UF
United Kingdom

ORCiD logoORCID ID 0000-0001-7265-5442
Phone 01634 830000
Email ranjit.akolekar@canterbury.ac.uk

Study information

Study designRetrospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeScreening
Participant information sheet None needed (retrospective study)
Scientific titleMaternal and neonatal outcomes in pregnancies with macrosomia
Study objectivesThe aim of this study is firstly, to compare the prevalence of pregnancy complications in pregnancies with big babies compared to those that are not; secondly, to determine whether complications in pregnancies with big babies can be predicted effectively from maternal and pregnancy characteristics and thirdly, in pregnancies that are deemed to be high risk, we aim to assess whether delivery at an earlier gestation is associated with a reduction in the incidence of adverse outcomes.
Ethics approval(s)Not provided at the time of registration

Awaiting approval from London - City & East Research Ethics Committee (Henry VIII Committee Room, St Bartholomew's Hospital, North Wing, EC1A 7BE; 0207 1048033; nrescommittee.london-cityandeast@nhs.net), ref: 19/LO/0502 (IRAS ID 262280).
Health condition(s) or problem(s) studiedPregnancy complications in big babies
InterventionThis is a retrospective cohort study undertaken at the Fetal Medicine Unit at a large maternity unit in United Kingdom. In our unit, all women who book for their pregnancy care are offered routine scans at 11-13 weeks, 20-22 weeks and 35-37 weeks for assessment of fetal anatomy, fetal growth and well-being. At the 11-13 weeks’ and 20-22 weeks’ gestation, we record maternal demographic characteristics and obtain detailed medical and obstetric history to allow for risk assessment of pregnancies at risk of placental dysfunction. Women who are diagnosed with large for gestational age at 35-37 weeks are offered an additional scan at 39-40 weeks’ gestation to assess fetal growth and well-being.

There is a specific dedicated team of fellows and sonographers who are trained in advanced obstetric ultrasound scanning who carry out an ultrasound scan to assess fetal growth and well-being by examination of fetal biometry, amniotic fluid and feto-placental Dopplers. Women who have a diagnosis of large for gestational age pregnancies are referred to the Fetal Medicine Consultant for a discussion about the risks and benefits of timing and mode of delivery.

The inclusion criteria for this study will include singleton pregnancies during the study period and those that delivered a phenotypically normal neonate after 24 weeks’ gestation. We excluded multiple pregnancies, miscarriages, termination of pregnancies, those with major fetal defects and pregnancies lost to follow-up.
Intervention typeOther
Primary outcome measureThe primary outcome measures were divided into maternal and neonatal complications.
Maternal complications:
1. Rates of emergency cesarean section, post-partum haemorrhage and obstetric anal sphincter injury (OASIS).
Neonatal complications:
1. Rates of shoulder dystocia, obstetric brachial plexus injury, birth fractures and hypoxic-ischaemic encephalopathy.
Secondary outcome measuresMaternal secondary outcome measures:
Rates of:
1. Prolonged 1st and 2nd stage of labor
2. Instrumental vaginal delivery
3. Failed instrumental delivery requiring cesarean section
4. Emergency cesarean section for failure to progress.
Overall study start date01/06/2018
Completion date01/05/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsApproximately 40,000 pregnancies, including about 4,000 with birthweight > 4,000g and about 500-600 with birthweight > 4,500 g.
Total final enrolment35548
Key inclusion criteria1. Singleton pregnancies which booked and delivered at our hospital during the study period
2. Delivered phenotypically normal neonates at ≥ 24 weeks’ gestation
Key exclusion criteria1. Multiple pregnancies
2. Miscarriages
3. Terminations of pregnancy
4. Major fetal defects
5. Lost to follow-up
Date of first enrolment01/01/2009
Date of final enrolment01/03/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medway NHS Foundation Trust
Fetal Medicine Unit
Level 2, Green Zone
Windmill Road
Gillingham
ME7 5NY
United Kingdom

Sponsor information

Medway NHS Foundation Trust
Hospital/treatment centre

Research and Innovation Department
Windmill Road
Gillingham
ME7 5NY
England
United Kingdom

Phone 01634830000 ext 3129
Email hayley.beresford1@nhs.net
Website NA
ROR logo "ROR" https://ror.org/01apxt611

Funders

Funder type

Government

Health Education England, Kent Surrey and Sussex

No information available

Results and Publications

Intention to publish date01/04/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planWe aim to publish the data in peer-reviewed scientific journals.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/09/2019 29/03/2021 Yes No
HRA research summary 26/07/2023 No No

Editorial Notes

29/03/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.