Induction of Labor Affected Fetus / NewbornPhase 4RANDNCT04280874
Induction of Labor in Term Pregnancies With Unfavourable Cervix
A Phase 4 study testing Dinoprostone 0.5 MG and Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly in people with Induction of Labor Affected Fetus / Newborn and Prostaglandins Causing Adverse Effects in Therapeutic Use, run by Clinical Hospital Merkur at 1 site in Croatia.
Trial summary
This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn, Prostaglandins Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Dinoprostone 0.5 MG and Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Dec 2018to 1 Jul 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- term pregnancies (> 37 weeks gestation)
- unfavourable cervix (Bishop score <6)
- indication for labor induction
- absence of uterine contractions
- reassuring cardiotocography
Who cannot join
- ruptured membranes
- scar uterus (previous caesarean section or uterus surgery)
- pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.
Read the detailed description
This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.
- Conditions
- Induction of Labor Affected Fetus / Newborn, Prostaglandins Causing Adverse Effects in Therapeutic Use
- Being tested
- Dinoprostone 0.5 MG, Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
- Keywords
- dinoprostone, Bishop score, labor induction, term pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone 0.5 MGDrug
Also called PREPIDIL
0.5mg dinoprostone applied intracervically
Dinoprostone 2 MG/2.5 ML Vaginal Gel/JellyDrug
Also called PROSTIN
2mg dinoprostone applied intravaginally
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | 106 randomly selected pregnant women Receives: Drug: Dinoprostone 0.5 MG |
| GROUP B | Active comparator | 106 randomly selected pregnant women Receives: Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
time period between beginning of labor induction to delivery
hours (difference of 4 hours or more is considered significant)
Measured: 5 days
Secondary outcomes (3)
number of births within 24h of start of labor induction
N (%)
Measured: 7 days
number of deliveries by caesarean section or instrumental deliveries
N (%)
Measured: 7 days
number of uterus hyperstimulation
N (%)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start10 Dec 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- 212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Merkur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Vince, Clinical Hospital Merkur
- Investigators
- Katja Vince, MD, Study chair, Clinical Hospital Merkur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280874
- Sponsor's protocol ID
- RANDOM1
- Acronym
- RAND
- Status last verified
- Jul 2020
- First submitted
- 14 Feb 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
- ClinicalTrials.gov ID
- NCT04280874
- Acronym / sponsor ID
- RAND / RANDOM1
- Conditions
- Induction of Labor Affected Fetus / Newborn, Prostaglandins Causing Adverse Effects in Therapeutic Use
- Keywords
- dinoprostone, Bishop score, labor induction, term pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Clinical Hospital MerkurUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Feb 2020 (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.
This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.
Detailed description
This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Drug: Dinoprostone 0.5 MG106 randomly selected pregnant women |
| GROUP B | Active comparator | Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly106 randomly selected pregnant women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- term pregnancies (> 37 weeks gestation)
- unfavourable cervix (Bishop score <6)
- indication for labor induction
- absence of uterine contractions
- reassuring cardiotocography
Key exclusion criteria (3 listed)
- ruptured membranes
- scar uterus (previous caesarean section or uterus surgery)
- pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
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 |
|---|---|---|
| Dinoprostone 0.5 MGAlso: PREPIDIL0.5mg dinoprostone applied intracervically | Drug | GROUP A |
| Dinoprostone 2 MG/2.5 ML Vaginal Gel/JellyAlso: PROSTIN2mg dinoprostone applied intravaginally | Drug | GROUP B |
Primary outcome
time period between beginning of labor induction to delivery
Time frame: 5 days
hours (difference of 4 hours or more is considered significant)
3 secondary outcomes
number of births within 24h of start of labor induction
Time frame: 7 days
number of deliveries by caesarean section or instrumental deliveries
Time frame: 7 days
number of uterus hyperstimulation
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- 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.
Katja Vince, MD study chair
Clinical Hospital Merkur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dinoprostone 0.5 MG and Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly in people with Induction of Labor Affected Fetus / Newborn and Prostaglandins Causing Adverse Effects in Therapeutic Use, run by Clinical Hospital Merkur at 1 site in Croatia.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jul 2020. 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 Croatia. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time period between beginning of labor induction to delivery (time frame: 5 days). 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 21 Jul 2020.