Induction of LaborPhase 2PRODUCTNCT02956785
What After the First Propess
A Phase 2 study testing 10 mg Dinoprostone; CTS, UK, 3 mg Dinoprostone vaginal tablet; Pfizer, UK and Aquacryl hydrogel rod; HPSRx Enterprises, USA in people with Induction of Labor, run by South Warwickshire NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- 10 mg Dinoprostone; CTS, UK, 3 mg Dinoprostone vaginal tablet; Pfizer, UK and Aquacryl hydrogel rod; HPSRx Enterprises, USA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What After the First Propess. A Randomised Comparative Prospective Study
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
Read the 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
- Conditions
- Induction of Labor
- Being tested
- 10 mg Dinoprostone; CTS, UK, 3 mg Dinoprostone vaginal tablet; Pfizer, UK, Aquacryl hydrogel rod; HPSRx Enterprises, USA
- Keywords
- Propess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg Dinoprostone; CTS, UKDrug
Also called Propess
3 mg Dinoprostone vaginal tablet; Pfizer, UKDrug
Also called Prostin
Aquacryl hydrogel rod; HPSRx Enterprises, USADrug
Also called Dilapan-S
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of achieving spontaneous or artificial rupture of membranes
percentage of women who will have spontaneous or artificial rupture of membranes
Measured: 12 months
Secondary outcomes (7)
Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes
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
Measured: 12 months
Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds)
percentage of women who will develop uterine hyperstimulation
Measured: 12 months
Rate of abnormal CTG changes needing intervention
percentage of women with non-reassuring or abnormal CTG that need intervention
Measured: 12 months
Rate of need for tocolysis
percentage of women who need tocolysis to treat hyperstimulation
Measured: 12 months
Rate of emergency Caesarean section
percentage of women who need Caesarean section for fetal distress or failed induction/progress of labour
Measured: 12 months
Grades of Caesarean sections
percentage of each of grade 1,2 and 3 Caesarean sections among each group
Measured: 12 months
Women's satisfaction with the method of induction used
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2022
- Study completionNov 2022
Why it stopped: Inability to recruit more women because of the COVID-19 and staffing/resources issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Warwickshire NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medicem International, Walsall Healthcare NHS Trust
- Responsible party
- Principal investigator, Amr Farag, Walsall Healthcare NHS Trust
- Investigators
- Amr H Farag, Consultant, Principal investigator, Walsall Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956785
- Sponsor's protocol ID
- 202984
- Acronym
- PRODUCT
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2016
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What After the First Propess. A Randomised Comparative Prospective Study
- ClinicalTrials.gov ID
- NCT02956785
- Acronym / sponsor ID
- PRODUCT / 202984
- Conditions
- Induction of Labor
- Keywords
- Propess
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit more women because of the COVID-19 and staffing/resources issues
- Enrolment
- 85 participants (actual)
- Lead sponsor
- South Warwickshire NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medicem International, Walsall Healthcare NHS Trust
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extension of propess+/-second propess | Active comparator | Drug: 10 mg Dinoprostone; CTS, UKWomen 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 |
| Prostin | Active comparator | Drug: 3 mg Dinoprostone vaginal tablet; Pfizer, UKWomen 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. |
| Dilapan-S | Active comparator | Drug: Aquacryl hydrogel rod; HPSRx Enterprises, USAWomen 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women booked for induction of labor at 37 to 42 weeks gestation
- Viable singleton pregnancy.
- Cephalic presentation.
- Intact membranes.
- No previous Caesarean section.
Key exclusion criteria (8 listed)
- Pregnancy less than completed 37 weeks or more than 42 weeks.
- Multiple pregnancy.
- Intrauterine fetal death.
- Non-cephalic presentation.
- Pre-labor rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg Dinoprostone; CTS, UKAlso: Propess | Drug | Extension of propess+/-second propess |
| 3 mg Dinoprostone vaginal tablet; Pfizer, UKAlso: Prostin | Drug | Prostin |
| Aquacryl hydrogel rod; HPSRx Enterprises, USAAlso: Dilapan-S | Drug | Dilapan-S |
Primary outcome
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
7 secondary outcomes
Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes
Time frame: 12 months
Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds)
Time frame: 12 months
Rate of abnormal CTG changes needing intervention
Time frame: 12 months
Rate of need for tocolysis
Time frame: 12 months
Rate of emergency Caesarean section
Time frame: 12 months
Grades of Caesarean sections
Time frame: 12 months
Women's satisfaction with the method of induction used
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Inability to recruit more women because of the COVID-19 and staffing/resources issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Related trials for Induction of Labor
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr H Farag, Consultant principal investigator
Walsall Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 mg Dinoprostone; CTS, UK, 3 mg Dinoprostone vaginal tablet; Pfizer, UK and Aquacryl hydrogel rod; HPSRx Enterprises, USA in people with Induction of Labor, run by South Warwickshire NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit more women because of the COVID-19 and staffing/resources issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of achieving spontaneous or artificial rupture of membranes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.