Condition category
Pregnancy and Childbirth
Date applied
27/02/2019
Date assigned
01/03/2019
Last edited
01/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ranjit Akolekar

ORCID ID

http://orcid.org/0000-0001-7265-5442

Contact details

Institute of Medical Sciences
Canterbury Christ Church University
Rowan Williams Court
30
Pembroke Court
Chatham
ME4 4UF
United Kingdom
01634 830000
ranjit.akolekar@canterbury.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

262820

Study information

Scientific title

Maternal and neonatal outcomes in pregnancies with macrosomia

Acronym

Study hypothesis

The 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

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).

Study design

Retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

None needed (retrospective study)

Condition

Pregnancy complications in big babies

Intervention

This 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 type

Other

Phase

Drug names

Primary outcome measure

The 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 measures

Maternal 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 trial start date

01/06/2018

Overall trial end date

01/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Singleton pregnancies which booked and delivered at our hospital during the study period
2. Delivered phenotypically normal neonates at ≥ 24 weeks’ gestation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Approximately 40,000 pregnancies, including about 4,000 with birthweight > 4,000g and about 500-600 with birthweight > 4,500 g.

Participant exclusion criteria

1. Multiple pregnancies
2. Miscarriages
3. Terminations of pregnancy
4. Major fetal defects
5. Lost to follow-up

Recruitment start date

01/01/2009

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Medway NHS Foundation Trust

Sponsor details

Research and Innovation Department
Windmill Road
Gillingham
ME7 5NY
United Kingdom
01634830000 ext 3129
hayley.beresford1@nhs.net

Sponsor type

Hospital/treatment centre

Website

NA

Funders

Funder type

Government

Funder name

Health Education England, Kent Surrey and Sussex

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We aim to publish the data in peer-reviewed scientific journals.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/04/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes