Obstetric ComplicationNCT04536753
The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
An observational study of Obstetric Complication and Ultrasound, run by Newcastle University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetric Complication, Ultrasound, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Induction of labour
- Type of treatment
- Surgery or procedure
- How many people
- 845 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Induced labour of a singleton pregnancy at Northumbria Healthcare Foundation trust resulting in a delivery between 01/01/2018 and 31/12/2018.
- Inclusion in the LGA group means that the main indication for induction is recorded as suspected macrosomia.
- Inclusion in the Diabetic group means diabetes was pre-existing or arose in pregnancy, diagnosed by oral glucose tolerance testing from 24-30 weeks or by home blood glucose monitoring with standard thresholds as per NICE ng3. Induction had to be undertaken with diabetes as the (co)indication.
- Inclusion criteria for the control group was induction of labour at or after 280 days gestation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Benjamin Simpson
Newcastle upon Tyne, Tyne and Wear, NE24HH
About this study
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.
Read the detailed description
This is a retrospective cohort study of pregnant women taken from 3 groups; women with a suspected LGA fetus (LGA), women with diabetes (DM) and a control group of women that underwent induction of labour at or after 40 weeks. Scan accuracy using GROW and WHO charts in the LGA and DM cohorts was assessed using ROC curves and outcomes between the cohorts was compared.
- Conditions
- Obstetric Complication, Ultrasound, Induction of Labor Affected Fetus / Newborn, Fetal Growth Complications
- Being tested
- Induction of labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of labourProcedure or surgery
Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Induction of labour | |
| Control | All other women induced at or after 280 days of gestation Receives: Procedure: Induction of labour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Caesarean section and assisted delivery rates
Measured: 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.
Measured: through study completion, an average of 1 year
Estimated blood loss
Blood loss as estimated by the clinical team
Measured: through study completion, an average of 1 year
Obstetric Anal Sphincter Injury
Any tear involving the external anal sphincter and/or rectal mucosa
Measured: through study completion, an average of 1 year
Admission to special care baby unit (SCBU)
Admission of neonate to neonatal unit from labour ward
Measured: through study completion, an average of 1 year
Epidural rate
Use of epdiural analgesia intrapartum
Measured: through study completion, an average of 1 year
Birthweight
Neonatal weight as taken following delivery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536753
- Sponsor's protocol ID
- SIMPS01
- Status last verified
- Jul 2020
- First submitted
- 28 Aug 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
- ClinicalTrials.gov ID
- NCT04536753
- Acronym / sponsor ID
- SIMPS01
- Conditions
- Obstetric Complication, Ultrasound, Induction of Labor Affected Fetus / Newborn, Fetal Growth Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 845 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective cohort study of pregnant women taken from 3 groups; women with a suspected LGA fetus (LGA), women with diabetes (DM) and a control group of women that underwent induction of labour at or after 40 weeks. Scan accuracy using GROW and WHO charts in the LGA and DM cohorts was assessed using ROC curves and outcomes between the cohorts was compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected large for gestational age (LGA) | – | Procedure: Induction of labourWomen 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. |
| Women with diabetes (DM) | – | Procedure: Induction of labourWomen with diabetes in pregnancy induced at between 259 and 266 days if on treatment and 273 days if gestational diabetes managed with diet alone. |
| Control | – | Procedure: Induction of labourAll other women induced at or after 280 days of gestation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Induced labour of a singleton pregnancy at Northumbria Healthcare Foundation trust resulting in a delivery between 01/01/2018 and 31/12/2018.
- Inclusion in the LGA group means that the main indication for induction is recorded as suspected macrosomia.
- Inclusion in the Diabetic group means diabetes was pre-existing or arose in pregnancy, diagnosed by oral glucose tolerance testing from 24-30 weeks or by home blood glucose monitoring with standard thresholds as per NICE ng3. Induction had to be undertaken with diabetes as the (co)indication.
- Inclusion criteria for the control group was induction of labour at or after 280 days gestation
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of labourInduction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol. | Procedure or surgery | Control, Suspected large for gestational age (LGA), Women with diabetes (DM) |
Primary outcome
Mode of delivery
Time frame: through study completion, an average of 1 year
Caesarean section and assisted delivery rates
Shoulder dystocia rate
Time frame: through study completion, an average of 1 year
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.
Estimated blood loss
Time frame: through study completion, an average of 1 year
Blood loss as estimated by the clinical team
Obstetric Anal Sphincter Injury
Time frame: through study completion, an average of 1 year
Any tear involving the external anal sphincter and/or rectal mucosa
Admission to special care baby unit (SCBU)
Time frame: through study completion, an average of 1 year
Admission of neonate to neonatal unit from labour ward
Epidural rate
Time frame: through study completion, an average of 1 year
Use of epdiural analgesia intrapartum
Birthweight
Time frame: through study completion, an average of 1 year
Neonatal weight as taken following delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Complication and Ultrasound, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery (time frame: through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.