Trial Outcomes & Findings for Transperineal Ultrasound to Assess the Progress of Labour (NCT NCT02430038)

Results Overview

Number of Caesarean deliveries in the prediction group

Recruitment status

COMPLETED

Target enrollment

584 participants

Primary outcome timeframe

24 months

Results posted on

2024-10-08

Participant Flow

This study aimed to firstly assess the feasibilty and acceptability of transperineal ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital vaginal examination (VE). Secondly, in all term (37-42 weeks) labouring women, we aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.

Recruitment start date 22/04/2015 Recruitment end date 19/01/2018

Participant milestones

Participant milestones
Measure	Acceptability Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Feasibility Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Predictive Model Nulliparous term labouring women with cephalic presentation
Overall Study STARTED	119	195	270
Overall Study Minimum Recruitment	42	100	270
Overall Study COMPLETED	119	195	269
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transperineal Ultrasound to Assess the Progress of Labour

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acceptability and Feasibilty n=119 Participants Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Feasibility n=195 Participants Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Predictive Model n=270 Participants Nulliparous term labouring women with cephalic presentation	Total n=584 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 5.3 • n=5 Participants	31 years STANDARD_DEVIATION 4.8 • n=7 Participants	31.0 years STANDARD_DEVIATION 5.1 • n=5 Participants	31 years STANDARD_DEVIATION 5.0 • n=4 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	195 Participants n=7 Participants	270 Participants n=5 Participants	584 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants	195 Participants n=7 Participants	270 Participants n=5 Participants	584 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Regional analgesia	95 Participants n=5 Participants	178 Participants n=7 Participants	211 Participants n=5 Participants	484 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Total number of Caesarean deliveries

Number of Caesarean deliveries in the prediction group

Outcome measures

Outcome measures
Measure	Acceptability Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Feasibility Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Predictive Model n=269 Participants Nulliparous term labouring women with cephalic presentation
Caesarean Delivery	—	—	79 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Only analysing patients in the acceptability arm for this primary outcome

Acceptability of transabdominal and transperineal ultrasound to pregnant and labouring women. Use of modified W-DEQ questionnaires pre and post assessment. We recorded the number of women who completed both questionnaires.

Outcome measures

Outcome measures
Measure	Acceptability n=119 Participants Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Feasibility Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Predictive Model Nulliparous term labouring women with cephalic presentation
Acceptability of Intrapartum Ultrasound	104 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The outcome was the number of women who had all labour parameters measured by ultrasound.

The outcome was the number of women who had all labour parameters measured by ultrasound.

Outcome measures

Outcome measures
Measure	Acceptability Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Feasibility n=195 Participants Where vaginal examinations are best avoided e.g. vaginismus or contraindicated (PPROM) with controls	Predictive Model Nulliparous term labouring women with cephalic presentation
Feasibility of Ultrasound Labour Parameters	0 Participants	168 Participants	0 Participants

Adverse Events

Acceptability

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Feasibility of the Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Predictive Model

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Christoph Lees

Imperial College

Phone: 02083831000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place