Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

What After the First Propess (PRODUCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956785
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Medicem International
Information provided by (Responsible Party):
Amr Farag, South Warwickshire NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE October 29, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date April 18, 2018
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
Rate of achieving spontaneous or artificial rupture of membranes [ Time Frame: 12 months ]
percentage of women who will have spontaneous or artificial rupture of membranes
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
Rate of achieving spontaneous or artificial rupture of membranes [ Time Frame: 6 months ]
percentage of women who will have spontaneous or artificial rupture of membranes
Change History Complete list of historical versions of study NCT02956785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes [ Time Frame: 12 months ]
    The time frame is 6 months from the onset of the study till assessing the results, doing the analysis and presenting. But, the time interval stated as an outcome here is the period of time elapsing from starting induction of labour and rupturing the membranes whether spontaneous or artificial
  • Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds) [ Time Frame: 12 months ]
    percentage of women who will develop uterine hyperstimulation
  • Rate of abnormal CTG changes needing intervention [ Time Frame: 12 months ]
    percentage of women with non-reassuring or abnormal CTG that need intervention
  • Rate of need for tocolysis [ Time Frame: 12 months ]
    percentage of women who need tocolysis to treat hyperstimulation
  • Rate of emergency Caesarean section [ Time Frame: 12 months ]
    percentage of women who need Caesarean section for fetal distress or failed induction/progress of labour
  • Grades of Caesarean sections [ Time Frame: 12 months ]
    percentage of each of grade 1,2 and 3 Caesarean sections among each group
  • Women's satisfaction with the method of induction used [ Time Frame: 12 months ]
    scoring system based on women's questionnaire formed of 3 questions with a score of 3 to 15. In addition, evaluation of pain score out of 10
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes [ Time Frame: 6 months ]
  • Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds) [ Time Frame: 6 months ]
    percentage of women who will develop uterine hyperstimulation
  • Rate of abnormal CTG changes needing intervention [ Time Frame: 6 months ]
    percentage of women with non-reassuring or abnormal CTG that need intervention
  • Rate of need for tocolysis [ Time Frame: 6 months ]
    percentage of women who need tocolysis to treat hyperstimulation
  • Rate of emergency Caesarean section [ Time Frame: 6 months ]
    percentage of women who need Caesarean section for fetal distress or failed induction/progress of labour
  • Grades of Caesarean sections [ Time Frame: 6 months ]
    percentage of each of grade 1,2 and 3 Caesarean sections among each group
  • Women's satisfaction with the method of induction used [ Time Frame: 6 months ]
    scoring system based on women's questionnaire with a score of 0 to 25
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE What After the First Propess
Official Title  ICMJE What After the First Propess. A Randomised Comparative Prospective Study
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
Detailed Description

This randomized study will be carried out at delivery suite in Warwick Hospital after eligible women have been informed of the study when booked for induction of labor and provided with the study information leaflet

When attending for induction of labor on delivery suite, an informed consent will be obtained then all women will have a cardiotocogram (CTG) performed initially and will be assessed by vaginal examination and Bishop score recorded at insertion of first slow-release pessary (Propess®10 mg Dinoprostone; CTS, UK), which will be inserted high into the posterior vaginal fornix. Assessment and insertion of pessary will be done by an experienced obstetrician or a senior midwife

All women will be given the required care and support as per the local protocols and guidelines

Women will be excluded from the study within the first 24 hours of induction of labor in the following conditions:

  • Women with abnormal or non-reassuring CTG needing intervention.
  • Women needing tocolytic use.
  • Women needing removal of the Dinoprostone pessary.
  • Women needing emergency Caesarean section.
  • If spontaneous rupture of membranes occurs.
  • If artificial rupture of membranes is achievable after the first 24 hours of induction of labor (Bishop score 5 or more)
  • If woman withdraws her consent to continue as a part of the study.

After 24 hours from insertion of the first Dinoprostone pessary, women will be reassessed and a total of 330 women with Bishop score less than 7, will be randomly assigned to one of three intervention groups by a pre-formed computer-generated random list and randomization put in sealed opaque envelopes kept in a locked secure area on delivery suite.

Intervention groups will be as follows:

Group 1 (110 women):

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 (Currently Propess® is not licensed to be repeated as a second dose. However, there is a consensus that, the dose may be repeated after a consultant review and an informed verbal consent as per SWH 00190 Induction and Augmentation of the First and Second Stage of Labour Management Guideline, 2012).

Group 2 (110 women):

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.

Group 3 (110 women):

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.

For all participants, after achieving spontaneous or artificial rupture of membranes, the local protocol for intrapartum care will be followed and after delivery, the women will be asked to fill in a patient's satisfaction questionnaire about the process of induction, care given and being a part of the study

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Induction of Labor
Intervention  ICMJE
  • Drug: 10 mg Dinoprostone; CTS, UK
    Other Name: Propess
  • Drug: 3 mg Dinoprostone vaginal tablet; Pfizer, UK
    Other Name: Prostin
  • Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USA
    Other Name: Dilapan-S
Study Arms  ICMJE
  • Active Comparator: Extension of propess+/-second propess
    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
    Intervention: Drug: 10 mg Dinoprostone; CTS, UK
  • Active Comparator: Prostin
    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.
    Intervention: Drug: 3 mg Dinoprostone vaginal tablet; Pfizer, UK
  • Active Comparator: Dilapan-S
    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.
    Intervention: Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jo Williams, R&D Lead 01926495321 ext 4411 jo.williams@swft.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956785
Other Study ID Numbers  ICMJE 202984
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amr Farag, South Warwickshire NHS Foundation Trust
Study Sponsor  ICMJE South Warwickshire NHS Foundation Trust
Collaborators  ICMJE Medicem International
Investigators  ICMJE
Principal Investigator: Amr H Farag, Specialty Doctor South Warwickshire NHS Foundation Trust
PRS Account South Warwickshire NHS Foundation Trust
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP