Fetus or Newborn or Maternal; Effects of Induction of LaborPhase 3NCT02720978
Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin
A Phase 3 study testing Intravenous oxytocin and vaginal prostaglandin in people with Fetus or Newborn or Maternal; Effects of Induction of Labor, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetus or Newborn or Maternal; Effects of Induction of Labor
- What is being tested?
- Intravenous oxytocin and vaginal prostaglandin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2019
- Phase
- Phase 3
- 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 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- rupture of membranes in BISHOP score lower than 7.
- Pregnancy week 34+0 and onward.
- Singleton pregnancy.
- Verifying fetal monitoring.
- Normal maternal temperature (lower than 37.8)
- Without vaginal bleeding or suspected placental separation
- Contractions in frequency of less than 3 in 10 minutes
- Signed consent form.
Who cannot join
- Multiple pregnancy.
- Maternal age below 18 or over 42.
- Active labor
- Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm.
- Lack of consent to participate in the study
About this study
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.
Read the detailed description
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.
Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.
- Being tested
- Intravenous oxytocin, vaginal prostaglandin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous oxytocinDrug
Intravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
Induction according to departmental protocol of each delivery way. Data collecting after the delivery.
vaginal prostaglandinDrug
Vaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
Induction according to departmental protocol of each delivery way. Data collecting after the delivery.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous oxytocin | Experimental | Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7.
Those who agreed to participate in the study after signing an informed consent form will undergo the following steps:
1. Verification rupture of membranes and gestational age.
2. Choosing the treatment group Intravenous oxytocin from red envelope, randomly.
3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
4. Induction according to departmental protocol of each delivery way.
5. Data collecting after the delivery. Receives: Drug: Intravenous oxytocin |
| vaginal prostaglandin | Experimental | Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7.
Those who agreed to participate in the study after signing an informed consent form will undergo the following steps:
1. Verification rupture of membranes and gestational age.
2. Choosing the treatment group vaginal prostaglandin from red envelope, randomly.
3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
4. Induction according to departmental protocol of each delivery way.
5. Data collecting after the delivery. Receives: Drug: vaginal prostaglandin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration from the beginning of labor induction until delivery
Measured: 5 days
Secondary outcomes (1)
Duration of labor induction from rupture of membranes until delivery.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetus or Newborn or Maternal; Effects of Induction of LaborStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sharon Maslovitz, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720978
- Sponsor's protocol ID
- 0073-15-TLV
- Status last verified
- May 2016
- First submitted
- 22 Mar 2016
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin
- ClinicalTrials.gov ID
- NCT02720978
- Acronym / sponsor ID
- 0073-15-TLV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 28 Mar 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.
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.
Detailed description
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.
Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous oxytocin | Experimental | Drug: Intravenous oxytocinWomen that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps: 1. Verification rupture of membranes and gestational age. 2. Choosing the treatment group Intravenous oxytocin from red envelope, randomly. 3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. 4. Induction according to departmental protocol of each delivery way. 5. Data collecting after the delivery. |
| vaginal prostaglandin | Experimental | Drug: vaginal prostaglandinWomen that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps: 1. Verification rupture of membranes and gestational age. 2. Choosing the treatment group vaginal prostaglandin from red envelope, randomly. 3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar. 4. Induction according to departmental protocol of each delivery way. 5. Data collecting after the delivery. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- rupture of membranes in BISHOP score lower than 7.
- Pregnancy week 34+0 and onward.
- Singleton pregnancy.
- Verifying fetal monitoring.
- Normal maternal temperature (lower than 37.8)
Key exclusion criteria (5 listed)
- Multiple pregnancy.
- Maternal age below 18 or over 42.
- Active labor
- Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm.
- Lack of consent to participate in the study
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 |
|---|---|---|
| Intravenous oxytocinIntravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery. | Drug | Intravenous oxytocin |
| vaginal prostaglandinVaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery. | Drug | vaginal prostaglandin |
Primary outcome
The duration from the beginning of labor induction until delivery
Time frame: 5 days
1 secondary outcome
Duration of labor induction from rupture of membranes until delivery.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Individual participant dataSharing planned: No
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.
Sharon Maslovitz, MD principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous oxytocin and vaginal prostaglandin in people with Fetus or Newborn or Maternal; Effects of Induction of Labor, run by Tel-Aviv Sourasky Medical Center.
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 5 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 26 May 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
The duration from the beginning of labor induction until 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 26 May 2016.