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Early Versus Late Amniotomy Following EAB Cervical Ripening

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ClinicalTrials.gov Identifier: NCT04216628
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
Wolfson Medical Center
Rambam Health Care Campus
The Baruch Padeh Medical Center, Poriya
Information provided by (Responsible Party):
Yael Ganor-Paz, Assuta Ashdod Hospital

Brief Summary:
The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

Condition or disease Intervention/treatment Phase
Induction of Labor Affected Fetus / Newborn Other: Amniotomy Not Applicable

Detailed Description:

Induction of labor is a common obstetric procedure with a reported rate of 23.3% in 2012 in the United State. It has been recently reported that Induction of labor at full term in uncomplicated singleton gestations is not associated with increased risk of cesarean delivery and overall has similar outcomes compared to expectant management.

Induction of labor in women with an unripened cervix is comprised of two stages, cervical ripening followed by augmentation of labor.

Extra amniotic balloon inflation is a widespread mechanical method of cervical ripening that commonly results in a ripened cervix open to 3-4 cm without significant uterine contractions. At this point the clinician may opt to perform artificial rupture of membranes or rather first begin oxytocin infusion delaying amniotomy to later stages of labor. A retrospective cohort showed early amniotomy after Foley balloon catheter removal was associated with shorter duration of labor induction among nulliparous women.In accordance, an RCT investigating the efficacy of early amniotomy in nulliparous women showed this practice resulted in labor shortening without increasing the rate of cesarean section, yet these women were treated by different methods for cervical ripening. Contradicting results were shown in a randomized controlled trial addressing the very question of early versus late amoniotomy after balloon ripening, concluding that postponing amniotomy until active labor commences results in a reduction of dystocia indicated cesarean section. However no distinction was made in this study between nulliparous and multiparous parturients. Since these comprise different groups with distinct labor curves, the question remains whether one should consider parity when deciding to perform early vs late amniotomy following balloon expulsion.

Both Amniotomy and Oxytocine infusion are part of the routine protocol and necessary procedures for induction of labor. Adverse outcome of amniotomy includes fetal heart rate changes, cord prolapse and intrapartum fever when labor is prolonged. Adverse outcome of oxytocine include hypertonus and fetal heart rate changes requiring cessation of oxytocine infusion (as in routine protocol) and intrapartum fever if labor is prolonged (not due to oxytocine infusion per se). Most of the patients admitted for induction of labor will need both amniotomy and oxytocine, however the role of the order of these two procedures is unclear ,as well as whether the order of these procedures affect the rate of adverse outcome.

The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

STUDY PROTOCOL Multicenter randomized control trial that will be conducted in 4 medical centers in Israel.

Women with a singleton viable gestation undergoing indicated labor induction at term (37-42 weeks of gestation) who undergoing induction of labor at term with a low bishop score<4 who require extra amniotic balloon cervical ripening will be asked to participate in the study. Written informed consent will be obtained from all patients.

Early amniotomy- Amniotomy performed as the exclusive primary intervention to augment labor following expulsion of the EAB regardless of cervical dilatation.

Late amniotomy- EAB expulsion is followed by oxytocin infusion at increasing increments as the primary intervention as an exclusive intervention for at least 2 hours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. For the early amniotomy group amniotomy will be performed as the exclusive primary intervention. Oxytocin infusion will begin as per local standard dose protocol no earlier than 2 hours following amniotomy.
  2. For the late amniotomy group oxytocin infusion will begin as per local standard dose protocol. Amniotomy will be performed no earlier than 2 hours following the commence of oxytocin infusion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Versus Late Amniotomy Following EAB Cervical Ripening - Does Parity Matter?
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Early amniotomy group
Amniotomy will be performed as the exclusive primary intervention. Oxytocin infusion will begin as per local standard dose protocol no earlier than 2 hours following amniotomy.
Other: Amniotomy
Artificial rupturing of membranes and IV infusion of Oxytocin
Other Name: Oxytocin

Late amniotomy group
Oxytocin infusion will begin as per local standard dose protocol. Amniotomy will be performed no earlier than 2 hours following the commence of oxytocin infusion
Other: Amniotomy
Artificial rupturing of membranes and IV infusion of Oxytocin
Other Name: Oxytocin




Primary Outcome Measures :
  1. Time to delivery [ Time Frame: Up to 96 Hours ]
    The time from induction defined as the primary intervention following balloon expulsion to delivery.

  2. Delivery within 24 hours [ Time Frame: Up to 96 Hours ]
    The proportion of women that delivered within 24 hours of induction


Secondary Outcome Measures :
  1. Cesarean delivery [ Time Frame: Up to 96 Hours ]
    Cesarean delivery rates and indications

  2. Operative delivery [ Time Frame: Up to 96 Hours ]
    Operative delivery rates and indications

  3. Intrapartum fever [ Time Frame: Up to 96 Hours ]
    Fever >38 degrees Celsius during labor

  4. Postpartum fever during the postpartum hospital stay [ Time Frame: Up to 7 days ]
    Fever >38 degrees Celsius > 24hours after delivery

  5. Post partum hemorrhage [ Time Frame: Up to 7 days ]
    Estimation of obstetrician >500cc bleeding post partum for vaginal delivery or>1000 cc at cesarean section

  6. Neonatal outcomes- Apgar [ Time Frame: 10 minutes ]
    Apgar score

  7. Neonatal outcomes - PH umbilical [ Time Frame: 10 minutes ]
    PH of vein and or artery of umbilical cord

  8. Neonatal outcomes- NICU admission [ Time Frame: Up to 30 days ]
    Admission to Neonatal Intensive Care Unit

  9. Neonatal outcomes- infection [ Time Frame: Up to 30 days ]
    Neonatal fever/sepsis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Induction of labor :

Women with a singleton viable gestation undergoing indicated labor induction at term (37-42 weeks of gestation).

Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Gestational age 37-42 weeks
  2. Singleton pregnancy
  3. Vertex presentation
  4. Medical indication for induction of labor
  5. Need for cervical ripening (Bishop score <=6)
  6. Consent to participate in the study
  7. Women age at or >18 years

Exclusion Criteria:

  1. Multiple pregnancies
  2. Preterm pregnancy
  3. Previous cesarean section
  4. Uterine malformation
  5. Withdrawal of consent.

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): NCT04216628


Contacts
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Contact: Yael Ganor Paz, MD 972-72-3398423 yaelgano@assuta.co.il

Locations
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Israel
Assuta Ashdod Recruiting
Ashdod, Israel
Contact: Yael Ganor Paz, MD       yaelgano@assuta.co.il   
Sponsors and Collaborators
Assuta Ashdod Hospital
Wolfson Medical Center
Rambam Health Care Campus
The Baruch Padeh Medical Center, Poriya
Investigators
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Principal Investigator: Yael Ganor Paz, MD Assuta Ashdod medical center
Publications:

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Responsible Party: Yael Ganor-Paz, Senior physician, OBGYN department, Assuta Ashdod Hospital
ClinicalTrials.gov Identifier: NCT04216628    
Other Study ID Numbers: 31-19-AAA
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yael Ganor-Paz, Assuta Ashdod Hospital:
Amniotomy
Cervical ripening
Oxytocin
Exrea amniotic baloon
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs