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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04477226
Other study ID # FF-2019-368
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2019

Study information

Verified date July 2020
Source Universiti Kebangsaan Malaysia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.


Description:

The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.


Recruitment information / eligibility

Status Completed
Enrollment 294
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Nulliparous or multipara

- Singleton live pregnancy

- Gestational age between 37 - 42 weeks

- Cephalic presentation

- Intact membranes

- Reactive cardiotocograph tracing

- Low risk pregnancy

Exclusion Criteria:

- Previous history of uterine surgery

- Low lying placenta, placenta praevia and vaginal bleeding

- Multiple pregnancy

- Preterm Prelabour rupture of membrane/ prelabour rupture of membranes

- Known allergy towards prostaglandins

- Intrauterine fetal death

- Known fetal anomaly

- Estimated fetal weight >3.8kg by scan

- Grandmultiparity (more than 5)

- BMI >40kg/m2

- Diabetes and hypertension on treatment

- Other medical illness on treatment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Transvaginal ultrasound scan
Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines

Locations

Country Name City State
Malaysia Universiti Kebangsaan Malaysia Medical Centre Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction measurement of cervical length in cm before induction of labour
See also
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