Premature Rupture of Membranes at TermPhase 4PESTIBORNCT04743297
Propess Versus Prostin for Induction of Labour in Women With Term PROM
A Phase 4 study testing Prostaglandin E2 (Propess) and Prostaglandin E2 (Prostin) in people with Premature Rupture of Membranes at Term and Induction of Labour, run by University Medical Centre Maribor.
Trial summary
Premature rupture of membranes (PROM) at term is a rupture that occurs at term (> 37 weeks) before the start of labor. The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor in women with term PROM Propess (Controlled release dinoprostone, Vaginal Delivery System) and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Rupture of Membranes at Term, Induction of Labour
- What is being tested?
- Prostaglandin E2 (Propess) and Prostaglandin E2 (Prostin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jan 2023
- Phase
- Phase 4
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Gestational age 37 weeks or more
- Singleton pregnancy
- Cephalic presentation
- Unfavorable cervix (BISHOP <6)
- No contraindications for vaginal delivery
- Without uterine surgery
- Without chorioamnionitis
Who cannot join
- Age less than 18 years
- Multiple gestation
- Previous cesarean section
- Suspected intraamniotic infection
- Any contraindication to vaginal delivery
- Bishop score >7
- Pathological ctg
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Labour Induction With the Propess Vaginal Delivery System vs. Labour Induction With the Prostin Vaginal Tablet in Case of a Prelabour Rupture of Membranes. PESTIBOR Randomized Controlled Trial
Premature rupture of membranes (PROM) at term is a rupture that occurs at term (> 37 weeks) before the start of labor.
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor in women with term PROM Propess (Controlled release dinoprostone, Vaginal Delivery System) and Prostin E2 (Dinoprostone vaginal Tablet).
Women will be randomised to two treatment groups.
Although some studies support efficacy of the Propess for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with PROM at term.
Read the detailed description
The study is going to include all pregnant women with in-term PROM (after week 37 of pregnancy) without contractions if they meet the inclusion criteria. If the cervix is still non-inducible after 4-6 hours and there are no contractions, the medication to be administered to them will be determined by means of computer randomization. The success rate of induction with Propess vs. Prostin tablets will be compared. Soon after PROM, there can be the onset of contractions and cervix dilation that lead to childbirth.
In case of some pregnant women, there are no contractions and cervix dilation even after the event despite PROM and water breaking. If the status remains unchanged, the risk of intrauterine infection, fetus infection, and later on an infection of the newborn increases. The expecting mother can also eventually lose hope for a successful vaginal birth and starts thinking about having a caesarean delivery. To avoid that, the investigators use medications that accelerate the onset of vaginal birth in clinical practice.
The investigators know several ways to induce labour after PROM. References give no clear and reliable data on the best approach. The investigators can use medications such as oxytocin, dinoprostone, or misoprostol.
Our ward has been using Prostin 3 mg (dinoprostone) vaginal tablets to induce labour in case of PROM for several years. They have proven to be an efficient and safe procedure in our clinical practice.
Propess is used for the induction of labor with intact membranes. Based on the information from references and according to our experience, the medication is highly effective and safe, as well as easy to use.
Our study aims at establishing whether it can also be used with pregnant women with PROM.
- Being tested
- Prostaglandin E2 (Propess), Prostaglandin E2 (Prostin)
- Keywords
- Induction, PROM, Propess, Prostin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin E2 (Propess)Drug
Also called dinoprostone
Propess - The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour or at the occurrence of hyperstimulation.
Prostaglandin E2 (Prostin)Drug
Also called dinoprostone
Prostin - 3 mg vaginal tablet is placed in the posterior vaginal fornix. Dose can be repeated every 8 hours till onset of active labour or the occurrence of hyper-stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Propess Vaginal Delivery System | Active comparator | Propess - Prostaglandin E2 Vaginal Delivery System. Slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h. Receives: Drug: Prostaglandin E2 (Propess) |
| Prostin Tablet | Active comparator | Prostaglandin E2 Vaginal Tablet 3 mg dinoprostone Receives: Drug: Prostaglandin E2 (Prostin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction to Delivery Interval
Measured: 24 hours
Induction to Onset of labor Interval
Measured: 24 hours
Secondary outcomes (2)
Frequency of Cesarean Sections
Measured: 24 hours
Frequency of Failed Induction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Premature Rupture of Membranes at TermStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronika Anzeljc, Study chair, Maribor University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743297
- Sponsor's protocol ID
- IRP-2020/01-04
- Acronym
- PESTIBOR
- Status last verified
- Feb 2021
- First submitted
- 26 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mynarek M, Bjellmo S, Lydersen S, Strand KM, Afset JE, Andersen GL, Vik T. Prelabor rupture of membranes and the association with cerebral palsy in term born children: a national registry-based cohort study. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):67. doi: 10.1186/s12884-020-2751-3.
PubMed 32005186National Collaborating Centre for Women's and Children's Health. National Institute for Health and Care Excellence: Clinical Guidelines. Intrapartum Care: Care of Healthy Women and Their Babies During Childbirth. London: National Institute for Health and Care Excellence (UK) Copyright (c) 2014 National Collaborating Centre for Women's and Children's Health.; 2014
Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
PubMed 8598837Zlatnik FJ. Management of premature rupture of membranes at term. Obstet Gynecol Clin North Am. 1992 Jun;19(2):353-64.
PubMed 1630743Geethanath RM, Ahmed I, Abu-Harb M, Onwuneme C, McGarry K, Hinshaw K. Intrapartum antibiotics for prolonged rupture of membranes at term to prevent Group B Streptococcal sepsis. J Obstet Gynaecol. 2019 Jul;39(5):619-622. doi: 10.1080/01443615.2018.1550474. Epub 2019 Mar 27.
PubMed 30917724Ivars J, Garabedian C, Devos P, Therby D, Carlier S, Deruelle P, Subtil D. Simplified Bishop score including parity predicts successful induction of labor. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:309-14. doi: 10.1016/j.ejogrb.2016.06.007. Epub 2016 Jul 5.
PubMed 27423032Athiel Y, Crequit S, Bongiorno M, Sanyan S, Renevier B. Term prelabor rupture of membranes: Foley catheter versus dinoprostone as ripening agent. J Gynecol Obstet Hum Reprod. 2020 Oct;49(8):101834. doi: 10.1016/j.jogoh.2020.101834. Epub 2020 Jun 22.
PubMed 32585393Freret TS, Chacon KM, Bryant AS, Kaimal AJ, Clapp MA. Oxytocin Compared to Buccal Misoprostol for Induction of Labor after Term Prelabor Rupture of Membranes. Am J Perinatol. 2021 Feb;38(3):224-230. doi: 10.1055/s-0039-1696642. Epub 2019 Sep 6.
PubMed 31491801Cheung PC, Yeo EL, Wong KS, Tang LC. Oral misoprostol for induction of labor in prelabor rupture of membranes (PROM) at term: a randomized control trial. Acta Obstet Gynecol Scand. 2006;85(9):1128-33. doi: 10.1080/00016340600589636.
PubMed 16929421Hu YP, Zhou D, Li M, Wang Y, Wang L, Sun GQ, Xiao M. Use of labor induction with dinoprostone vaginal suppositories in pregnant women with gestational hypertension. J Obstet Gynaecol Res. 2019 Nov;45(11):2185-2192. doi: 10.1111/jog.14092. Epub 2019 Aug 27.
PubMed 31456315Shirley M. Dinoprostone Vaginal Insert: A Review in Cervical Ripening. Drugs. 2018 Oct;78(15):1615-1624. doi: 10.1007/s40265-018-0995-2.
PubMed 30317521Pajntar M, Lučovnik M. Normalni porod in vodenje poroda. v knjigi Nosečnost in vodenje poroda. Ured. Pajntar M, Novak Antolič Ž, Lučovnik M. Medicinski razgledi 2015. Tretja dopolnjena izdaja. 231-50.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labour Induction With the Propess Vaginal Delivery System vs. Labour Induction With the Prostin Vaginal Tablet in Case of a Prelabour Rupture of Membranes. PESTIBOR Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04743297
- Acronym / sponsor ID
- PESTIBOR / IRP-2020/01-04
- Keywords
- Induction, PROM, Propess, Prostin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 8 Feb 2021 (actual)
- 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.
Premature rupture of membranes (PROM) at term is a rupture that occurs at term (> 37 weeks) before the start of labor.
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor in women with term PROM Propess (Controlled release dinoprostone, Vaginal Delivery System) and Prostin E2 (Dinoprostone vaginal Tablet).
Women will be randomised to two treatment groups.
Although some studies support efficacy of the Propess for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with PROM at term.
Detailed description
The study is going to include all pregnant women with in-term PROM (after week 37 of pregnancy) without contractions if they meet the inclusion criteria. If the cervix is still non-inducible after 4-6 hours and there are no contractions, the medication to be administered to them will be determined by means of computer randomization. The success rate of induction with Propess vs. Prostin tablets will be compared. Soon after PROM, there can be the onset of contractions and cervix dilation that lead to childbirth.
In case of some pregnant women, there are no contractions and cervix dilation even after the event despite PROM and water breaking. If the status remains unchanged, the risk of intrauterine infection, fetus infection, and later on an infection of the newborn increases. The expecting mother can also eventually lose hope for a successful vaginal birth and starts thinking about having a caesarean delivery. To avoid that, the investigators use medications that accelerate the onset of vaginal birth in clinical practice.
The investigators know several ways to induce labour after PROM. References give no clear and reliable data on the best approach. The investigators can use medications such as oxytocin, dinoprostone, or misoprostol.
Our ward has been using Prostin 3 mg (dinoprostone) vaginal tablets to induce labour in case of PROM for several years. They have proven to be an efficient and safe procedure in our clinical practice.
Propess is used for the induction of labor with intact membranes. Based on the information from references and according to our experience, the medication is highly effective and safe, as well as easy to use.
Our study aims at establishing whether it can also be used with pregnant women with PROM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Propess Vaginal Delivery System | Active comparator | Drug: Prostaglandin E2 (Propess)Propess - Prostaglandin E2 Vaginal Delivery System. Slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h. |
| Prostin Tablet | Active comparator | Drug: Prostaglandin E2 (Prostin)Prostaglandin E2 Vaginal Tablet 3 mg dinoprostone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Gestational age 37 weeks or more
- Singleton pregnancy
- Cephalic presentation
- Unfavorable cervix (BISHOP <6)
Key exclusion criteria (7 listed)
- Age less than 18 years
- Multiple gestation
- Previous cesarean section
- Suspected intraamniotic infection
- Any contraindication to vaginal delivery
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 |
|---|---|---|
| Prostaglandin E2 (Propess)Also: dinoprostonePropess - The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour or at the occurrence of hyperstimulation. | Drug | Propess Vaginal Delivery System |
| Prostaglandin E2 (Prostin)Also: dinoprostoneProstin - 3 mg vaginal tablet is placed in the posterior vaginal fornix. Dose can be repeated every 8 hours till onset of active labour or the occurrence of hyper-stimulation. | Drug | Prostin Tablet |
Primary outcome
Induction to Delivery Interval
Time frame: 24 hours
Induction to Onset of labor Interval
Time frame: 24 hours
2 secondary outcomes
Frequency of Cesarean Sections
Time frame: 24 hours
Frequency of Failed Induction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 32005186Mynarek M, Bjellmo S, Lydersen S, Strand KM, Afset JE, Andersen GL, Vik T. Prelabor rupture of membranes and the association with cerebral palsy in term born children: a national registry-based cohort study. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):67. doi: 10.1186/s12884-020-2751-3.
- BackgroundNational Collaborating Centre for Women's and Children's Health. National Institute for Health and Care Excellence: Clinical Guidelines. Intrapartum Care: Care of Healthy Women and Their Babies During Childbirth. London: National Institute for Health and Care Excellence (UK) Copyright (c) 2014 National Collaborating Centre for Women's and Children's Health.; 2014
- Background: PubMed 8598837Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
- Background: PubMed 1630743Zlatnik FJ. Management of premature rupture of membranes at term. Obstet Gynecol Clin North Am. 1992 Jun;19(2):353-64.
- Background: PubMed 30917724Geethanath RM, Ahmed I, Abu-Harb M, Onwuneme C, McGarry K, Hinshaw K. Intrapartum antibiotics for prolonged rupture of membranes at term to prevent Group B Streptococcal sepsis. J Obstet Gynaecol. 2019 Jul;39(5):619-622. doi: 10.1080/01443615.2018.1550474. Epub 2019 Mar 27.
- Background: PubMed 27423032Ivars J, Garabedian C, Devos P, Therby D, Carlier S, Deruelle P, Subtil D. Simplified Bishop score including parity predicts successful induction of labor. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:309-14. doi: 10.1016/j.ejogrb.2016.06.007. Epub 2016 Jul 5.
- Background: PubMed 32585393Athiel Y, Crequit S, Bongiorno M, Sanyan S, Renevier B. Term prelabor rupture of membranes: Foley catheter versus dinoprostone as ripening agent. J Gynecol Obstet Hum Reprod. 2020 Oct;49(8):101834. doi: 10.1016/j.jogoh.2020.101834. Epub 2020 Jun 22.
- Background: PubMed 31491801Freret TS, Chacon KM, Bryant AS, Kaimal AJ, Clapp MA. Oxytocin Compared to Buccal Misoprostol for Induction of Labor after Term Prelabor Rupture of Membranes. Am J Perinatol. 2021 Feb;38(3):224-230. doi: 10.1055/s-0039-1696642. Epub 2019 Sep 6.
- Background: PubMed 16929421Cheung PC, Yeo EL, Wong KS, Tang LC. Oral misoprostol for induction of labor in prelabor rupture of membranes (PROM) at term: a randomized control trial. Acta Obstet Gynecol Scand. 2006;85(9):1128-33. doi: 10.1080/00016340600589636.
- Background: PubMed 31456315Hu YP, Zhou D, Li M, Wang Y, Wang L, Sun GQ, Xiao M. Use of labor induction with dinoprostone vaginal suppositories in pregnant women with gestational hypertension. J Obstet Gynaecol Res. 2019 Nov;45(11):2185-2192. doi: 10.1111/jog.14092. Epub 2019 Aug 27.
- Background: PubMed 30317521Shirley M. Dinoprostone Vaginal Insert: A Review in Cervical Ripening. Drugs. 2018 Oct;78(15):1615-1624. doi: 10.1007/s40265-018-0995-2.
- BackgroundPajntar M, Lučovnik M. Normalni porod in vodenje poroda. v knjigi Nosečnost in vodenje poroda. Ured. Pajntar M, Novak Antolič Ž, Lučovnik M. Medicinski razgledi 2015. Tretja dopolnjena izdaja. 231-50.
- Individual participant dataSharing planned: No
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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.
Veronika Anzeljc study chair
Maribor University Medical Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prostaglandin E2 (Propess) and Prostaglandin E2 (Prostin) in people with Premature Rupture of Membranes at Term and Induction of Labour, run by University Medical Centre Maribor.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika Anzeljc (+ 386 2 321 21 73, veronika.anzeljc@ukc-mb.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction to Delivery Interval (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743297, which also lists 12 linked publications.
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 15 Feb 2021.