NCT02956785

Brief Summary

The aim of this study is to compare three different regimens for continuation of induction of labor after no spontaneous or artificial rupture of membranes could be achieved after first 24 hours post-insertion of Dinoprostone

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5.8 years

First QC Date

October 29, 2016

Last Update Submit

November 9, 2022

Conditions

Induction of Labor

Keywords

Propess

Outcome Measures

Primary Outcomes (1)

  • Rate of achieving spontaneous or artificial rupture of membranes

    percentage of women who will have spontaneous or artificial rupture of membranes

    12 months

Secondary Outcomes (7)

  • Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes

    12 months

  • Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds)

    12 months

  • Rate of abnormal CTG changes needing intervention

    12 months

  • Rate of need for tocolysis

    12 months

  • Rate of emergency Caesarean section

    12 months

  • +2 more secondary outcomes

Study Arms (3)

Extension of propess+/-second propess

ACTIVE COMPARATOR

Women will have the initial slow-release Dinoprostone pessary left in place for six more hours (total of 30 hours in place) then removed followed by vaginal assessment 48 hours after the start of labour induction and insertion of a second slow-release pessary if required

Drug: 10 mg Dinoprostone; CTS, UK

Prostin

ACTIVE COMPARATOR

Women will have the initial slow-release Dinoprostone pessary removed followed by insertion of quick-release Dinoprostone tablet (Prostin® 3 mg Dinoprostone vaginal tablet; Pfizer, UK) high in the posterior vaginal fornix immediately after removal of the slow-release pessary. The tablet will be left for 6 hours followed by vaginal reassessment and insertion of a second tablet if ARM is still not achievable.

Drug: 3 mg Dinoprostone vaginal tablet; Pfizer, UK

Dilapan-S

ACTIVE COMPARATOR

Women will have the initial slow-release Dinoprostone pessary removed followed by insertion of 1-5 Osmotic cervical rods (Dilapan-S® Aquacryl hydrogel rod; HPSRx Enterprises, USA) by a senior obstetrician or a midwife into the cervical canal, immediately after removal of the slow-release pessary using a vaginal speculum and a holder. The rods will be left for 12-24 hours.

Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USA

Interventions

10 mg Dinoprostone; CTS, UKDRUG
Also known as: Propess
Extension of propess+/-second propess
3 mg Dinoprostone vaginal tablet; Pfizer, UKDRUG
Also known as: Prostin
Prostin
Aquacryl hydrogel rod; HPSRx Enterprises, USADRUG
Also known as: Dilapan-S
Dilapan-S

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women booked for induction of labor at 37 to 42 weeks gestation
  • Viable singleton pregnancy.
  • Cephalic presentation.
  • Intact membranes.
  • No previous Caesarean section.
  • No antenatal fetal concerns (Fetal growth restriction (FGR), small for gestational age (SGA), impaired Doppler, oligohydramnios, non-reassuring/abnormal CTG).

You may not qualify if:

  • Pregnancy less than completed 37 weeks or more than 42 weeks.
  • Multiple pregnancy.
  • Intrauterine fetal death.
  • Non-cephalic presentation.
  • Pre-labor rupture of membranes
  • Previous one or more Caesarean sections.
  • Antenatal concerns regarding fetal well-being (FGR, SGA, impaired Doppler, oligohydramnios, non-reassuring/abnormal CTG).
  • Non-reassuring or abnormal CTG on admission to labor ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walsall Healthcare NHS Trust

Walsall, WS2 9PS, United Kingdom

Location

MeSH Terms

Interventions

DinoprostoneKLK15 protein, human

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Amr H Farag, Consultant

    Walsall Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Obstetrician and Gynaecologist

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 7, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

GB(1)