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What After the First Propess (PRODUCT)

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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

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

Condition or disease Intervention/treatment Phase
Induction of Labor Drug: 10 mg Dinoprostone; CTS, UK Drug: 3 mg Dinoprostone vaginal tablet; Pfizer, UK Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USA Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: What After the First Propess. A Randomised Comparative Prospective Study
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: 10 mg Dinoprostone; CTS, UK
Other Name: Propess

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.
Drug: 3 mg Dinoprostone vaginal tablet; Pfizer, UK
Other Name: Prostin

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.
Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USA
Other Name: Dilapan-S




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. 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

  3. Rate of abnormal CTG changes needing intervention [ Time Frame: 12 months ]
    percentage of women with non-reassuring or abnormal CTG that need intervention

  4. Rate of need for tocolysis [ Time Frame: 12 months ]
    percentage of women who need tocolysis to treat hyperstimulation

  5. 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

  6. Grades of Caesarean sections [ Time Frame: 12 months ]
    percentage of each of grade 1,2 and 3 Caesarean sections among each group

  7. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956785


Contacts
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Contact: Jo Williams, R&D Lead 01926495321 ext 4411 jo.williams@swft.nhs.uk

Locations
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United Kingdom
South Warwickshire NHS Foundation Trust Recruiting
Warwick, Warwickshire, United Kingdom, CV345BW
Contact: Jo Williams, R&D lead    01926495321 ext 4411    jo.williams@swft.nhs.uk   
Contact: Amr H Farag, specialty doctor    01926495321 ext 4300    amr.farag@swft.nhs.uk   
Principal Investigator: Amr H Farag, specialty doctor         
Sub-Investigator: Olanrewaju O Sorinola, Consultant         
Sub-Investigator: Radhae Raghavan, Consultant         
Sub-Investigator: Sami G El-Daief, Consultant         
Sub-Investigator: David J D'souza, Consultant         
Sponsors and Collaborators
South Warwickshire NHS Foundation Trust
Medicem International
Investigators
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Principal Investigator: Amr H Farag, Specialty Doctor South Warwickshire NHS Foundation Trust

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Responsible Party: Amr Farag, Specialty Doctor Obstetrics and Gynaecology, South Warwickshire NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02956785     History of Changes
Other Study ID Numbers: 202984
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Amr Farag, South Warwickshire NHS Foundation Trust:
Propess
Additional relevant MeSH terms:
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Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs