Dinoprostone Vaginal Insert Clinical Trial
Official title:
Assessing, Depending on Personalized Manner, a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03050684 -
Does Vaginal Washing Affect the Success Rate of the Labour Induction?
|
N/A |