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Assessing a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert

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ClinicalTrials.gov Identifier: NCT03482531
Recruitment Status : Unknown
Verified May 2018 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 29, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date March 8, 2018
First Posted Date March 29, 2018
Last Update Posted Date May 30, 2018
Actual Study Start Date April 1, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2018)
Difference (in minutes) between the actual time to delivery compared to the predicted time [ Time Frame: 2 days ]
there will be different categories:
  • less than 180 minutes
  • more than 180 but less than 360 minutes
  • more than 360 but less than 540 minutes
  • more than 540 but less than 720 minutes
  • more than 720 minutes
Original Primary Outcome Measures
 (submitted: March 28, 2018)
rate of deliveries [ Time Frame: 2 years ]
rate of deliveries occurring between midnight and 6 a.m. following cervical ripening with dinoprostone vaginal insert.
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2018)
  • rate of deliveries [ Time Frame: 2 years ]
    rate of deliveries occurring between midnight and 6 a.m. following cervical ripening with dinoprostone vaginal insert.
  • the Apgar score [ Time Frame: 1, 3 and 5 minutes after delivery ]
    Apgar score lower than 7 at 1, 3 and 5 minutes. Apgar score lower than 7 at 5 minutes is correlated on the immediate child's development
  • neonatal potential of hydrogen (pH) [ Time Frame: 1 hour ]
    • mean of neonatal potential of hydrogen (pH)
    • potential of hydrogen < 7.20 means foetal acidosis
    • potential of hydrogen is measured in the artery of umbilical cordon few minutes after delivery
    • potential of hydrogen lower than 7 leads to foetal acidosis responsible for neonatal encephalopathy
  • neonatal intensive care hospitalization [ Time Frame: 12 hours ]
    The rate of neonatal intensive care hospitalization in the immediate postpartum and during the 12 hours after delivery
  • post-partum bleeding [ Time Frame: 24 hours ]
    • the rate of post-partum bleeding
    • postpartum hemorrhage is a bleeding more than 500ml
    • severe postpartum hemorrhage is a bleeding more than 1000ml
  • Operative deliveries [ Time Frame: 2 years ]
    the rate of forceps deliveries and vacuum extractions during the study duration
  • Cesarean sections [ Time Frame: 2 years ]
    the rate of cesarean sections during the study duration
Original Secondary Outcome Measures
 (submitted: March 28, 2018)
  • Difference (in minutes) between the actual time to delivery compared to the predicted time [ Time Frame: 2 days ]
    there will be different categories:
    • less than 180 minutes
    • more than 180 but less than 360 minutes
    • more than 360 but less than 540 minutes
    • more than 540 but less than 720 minutes
    • more than 720 minutes
  • the Apgar score [ Time Frame: 5 minutes after delivery ]
    Apgar score lower than 7 at 1, 3 and 5 minutes. Apgar score lower than 7 at 5 minutes is correlated on the immediate child's development
  • neonatal potential of hydrogen (pH) [ Time Frame: 1 hour ]
    • mean of neonatal potential of hydrogen (pH)
    • potential of hydrogen < 7.20 means foetal acidosis
    • potential of hydrogen is measured in the artery of umbilical cordon few minutes after delivery
    • potential of hydrogen lower than 7 leads to foetal acidosis responsible for neonatal encephalopathy
  • neonatal intensive care hospitalization [ Time Frame: 12 hours ]
    The rate of neonatal intensive care hospitalization in the immediate postpartum and during the 12 hours after delivery
  • post-partum bleeding [ Time Frame: 24 hours ]
    • the rate of post-partum bleeding
    • postpartum hemorrhage is a bleeding more than 500ml
    • severe postpartum hemorrhage is a bleeding more than 1000ml
  • Operative deliveries [ Time Frame: 2 years ]
    the rate of forceps deliveries and vacuum extractions during the study duration
  • Cesarean sections [ Time Frame: 2 years ]
    the rate of cesarean sections during the study duration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert
Official Title Assessing, Depending on Personalized Manner, a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert
Brief Summary

Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop <6), induction of labor is preceded by cervical ripening, usually with prostaglandins. The method of ripening most commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the morning, because of the higher availability of personnel (midwives and nurses). However, morning placement might increase the likelihood of the delivery occurring at night, since the mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies have now shown that the risk of obstetrical complications, as well as neonatal morbidity and mortality is increased when deliveries occur at night. Several factors have been suggested behind the increased morbidity at night, including the lower number of personnel working, the fatigue associated with night work and the disruption of the circadian rhythm, and the insufficient supervision of residents.

Very few studies have evaluated the importance of the timing of placement of the intravaginal dinoprostone insert, and its influence on the occurrence of night deliveries. Some investigators have recently performed a retrospective study at Angers university hospital that assessed the time interval between placing the dinoprostone vaginal insert and delivery, as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion increased the time to delivery. Moreover, the investigators proposed a regression equation that allows to calculate the mean time from insert placement to delivery for each patient, and have decided to incorporate it in the routine practice.

The investigators have decided to analyze the validity of the mathematical model. The consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal insert based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.

Detailed Description

This is a before-after, retrospective and prospective monocentric study. Patients in the "before" group were part of another study which are currently in the process of publishing and were retrospectively included, whereas patients in the "after" group will be prospectively included.

In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016. The main outcome of the previous study was to evaluate the time interval between placing the dinoprostone vaginal insert and delivery. One of the secondary objectives was to determine the factors that would impact the time to delivery. Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient:

Y = 961,188 - 80,346 x parity + 21,437 x Body Mass Index (BMI) - 165,263 x cervical dilation- 241,759 x Premature rupture of membranes.

Following this study, the investigators decided to modify the routine procedures on the maternity ward and incorporate the equation when scheduling patients for cervical ripening with vaginal dinoprostone insert. The aim is to have a more personalized insertion schedule that would lower the number of deliveries occurring between midnight and 6 a.m., since it has been proven that there is a higher risk of obstetrical morbidity with night-time labor and delivery.

The investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so 400 to 500 patients will be included during the study's duration. The investigators will then compare the outcomes in these patients that will comprise the "after" group, to the outcomes of patients in the "before" group, who delivered before the implementation of the new scheduling process. The investigators will thus be able to able to assess whether the mathematical model they suggested to estimate time to delivery and the personalized insertion timings have been confirmed. Then, subsequently, the objective is to analyze whether the use of the personalized scheduling based on the mathematical model they described would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.).

The research project has been approved by the ethics committee of Angers university hospital on January 31st, 2018.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All eligible patients with a vaginal dinoprostone insert for cervical ripening ( because of not favorable cervical conditions (bishop <6) and needing induction of labor)
Condition Dinoprostone Vaginal Insert
Intervention Other: mathematical model
mathematical model: regression equation that calculates the mean time from insert placement to delivery for each patient, based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes)
Study Groups/Cohorts
  • before group

    In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016.

    Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient.

  • after group

    The investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so the investigators will be able to include 400 to 500 patients during the study's duration.

    The equation will be incorporated when scheduling patients for cervical ripening with vaginal dinoprostone insert. The main objective of this study is to analyze to evaluate our mathematical model. One of the secondary objectives is to analyze whether the use of the personalized scheduling based on the mathematical model would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.).

    Intervention: Other: mathematical model
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 28, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • have cervical ripening with the dinoprostone vaginal insert
  • 34 weeks gestational age (GA) and beyond
  • singleton pregnancies
  • cephalic presentations

Exclusion Criteria:

  • term < 34 weeks GA
  • previous history of cesarean section
  • women who refuse to participate in the study or have their data used.
  • twin pregnancy
  • prostaglandin allergies
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03482531
Other Study ID Numbers PHRC 2018-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Angers
Study Sponsor University Hospital, Angers
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Angers
Verification Date May 2018