NCT04536753

Brief Summary

Best management of suspected large for gestational age (LGA) fetuses is unclear. In some hospitals women with an LGA fetus by customised growth charts are are offered earlier induction. This study aimed to examine scan accuracy for this group and the outcome with intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
845

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Last Updated

October 5, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

August 28, 2020

Last Update Submit

October 1, 2020

Conditions

Obstetric ComplicationUltrasoundInduction of Labor Affected Fetus / NewbornFetal Growth Complications

Outcome Measures

Primary Outcomes (7)

  • Mode of delivery

    Caesarean section and assisted delivery rates

    through study completion, an average of 1 year

  • Shoulder dystocia rate

    Any clinically diagnosed cases of shoulder dystocia where the shoulders did not deliver with routine axial traction on the next contraction after the head was delivered.

    through study completion, an average of 1 year

  • Estimated blood loss

    Blood loss as estimated by the clinical team

    through study completion, an average of 1 year

  • Obstetric Anal Sphincter Injury

    Any tear involving the external anal sphincter and/or rectal mucosa

    through study completion, an average of 1 year

  • Admission to special care baby unit (SCBU)

    Admission of neonate to neonatal unit from labour ward

    through study completion, an average of 1 year

  • Epidural rate

    Use of epdiural analgesia intrapartum

    through study completion, an average of 1 year

  • Birthweight

    Neonatal weight as taken following delivery

    through study completion, an average of 1 year

Other Outcomes (6)

  • Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chart

    through study completion, an average of 1 year

  • Birthweight centile as per customised chart

    through study completion, an average of 1 year

  • Birthweight centile as per WHO population chart

    through study completion, an average of 1 year

  • +3 more other outcomes

Study Arms (3)

Suspected large for gestational age (LGA)

Women with pregnancies suspected to be complicated by fetuses weighing more than the 90th centile on customised growth chart and induced for this reason prior to 287 days as the main indication without diabetes.

Procedure: Induction of labour

Women with diabetes (DM)

Women with diabetes in pregnancy induced at between 259 and 266 days if on treatment and 273 days if gestational diabetes managed with diet alone.

Procedure: Induction of labour

Control

All other women induced at or after 280 days of gestation

Procedure: Induction of labour

Interventions

Induction of labourPROCEDURE

Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.

ControlSuspected large for gestational age (LGA)Women with diabetes (DM)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women booked for their care at Northumbria Healthcare Trust in North East England: a predominantly white British female population with rates of obesity above the national average.

You may qualify if:

  • Induced labour of a singleton pregnancy at Northumbria Healthcare Foundation trust resulting in a delivery between 01/01/2018 and 31/12/2018.

You may not qualify if:

  • Previous caesarean section Multiple pregnancy Fetal concerns pre-induction: abnormal antenatal trace or abnormal doppler flow studies on antenatal ultrasound
  • Cases of induction for suspected LGA are to be excluded if there is a co-indication of obstetric cholestasis, hypertensive disorder or diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benjamin Simpson

Newcastle upon Tyne, Tyne and Wear, NE24HH, United Kingdom

Location

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 5, 2020

Record last verified: 2020-07

Locations

GB(1)