Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06324279 |
| Other study ID # |
000017585 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Ain Shams Maternity Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign,
in the prediction of success of induction of labor.
The prediction of outcome of induction of labor has always been an important topic to all
obstetricians. Bishop score is traditionally considered reliable way to predict the outcome
of induction of labor by assessing the cervical dilatation, effacement, position, and
consistence and assessing the level of the fetal head in the birth canal. Since The bishop
score remains a highly subjective method for prediction of outcome of induction of labor, the
use of sonographic measurements such as cervical sliding sign can be a better predictor of
successful induction of labor.The presence of CSS was defined as the sliding of the anterior
cervical lip on the posterior one under gentle pressure of the transvaginal probe.
Patients undergoing induction of labor with misoprostol will be checked for the cervical
sliding sign. The mode of delivery, induction to active labor time and active labor to
delivery time will be recorded and analysed to assess whether the sliding sign is an
independent predictor of success of induction.
Description:
Induction of labor is a common practice in modern obstetrics. It is the use of mechanical or
pharmacological -or both ways- to stimulate uterine contractions before spontaneous labor to
induce cervical dilatation and delivery. Induction of labor at term have many advantages. It
can reduce to risk of still birth. It also reduces the risk of macrosomia and its adverse
outcomes such as maternal trauma, shoulder dystocia or the need for instrumental delivery
(Kim, et al., 2019). However, induction of labor can also have adverse outcomes, the most
common is failure and increasing the risk of cesarean section. Induction of labor may not be
tolerated by some patients because of the potential increase in the duration of labor or a
prolonged latent phase. Increased cost compared to spontaneous delivery course and possible
neonatal morbidity if the gestational age is less than 39 weeks of gestation are other
drawbacks. (Kim, et al., 2019) Since the success of induction of labor is related to the
condition of the cervix, investigators have proposed the importance of having a reliable
system for determining the cervical maturity. A number of studies considered the use of
sonographic measurement of cervical length to predict the success of labor induction. The
sonographic marker for assessing the cervical softening called the cervical sliding sign
(CSS) which was introduced by (Volpe, et al., 2019), demonstrated its correlation with the
occurrence of impending delivery in women with preterm uterine contractions. The performance
of the CSS in predicting the success of IOL was conducted in two academic centers by (Volpe,
et al., 2022). However, its generalizability to community hospitals cannot be certain and
needs further testing. The presence of CSS was defined as the sliding of the anterior
cervical lip on the posterior one under gentle pressure of the transvaginal probe. (Volpe, et
al., 2022)
Aim/ Objectives. Assess the role of the cervical sliding sign (CSS) as a marker in the
prediction of the outcome of induction of labor (IOL) at term gestation.
Research Hypothesis:
The presence of Cervical Sliding sign in pregnant women at term gestation planned for
Induction of labor predicts a higher chance of vaginal delivery within 24 hours.
Research Question:
Is CSS a successful marker for prediction of outcome of induction of labor in pregnant women
at term gestation? Methodology
Type of Study: Prospective observational cohort study Study Setting: Ain Shams University
Maternity Hospital (labor ward). Study period: 6 months Study Population: The study will be
conducted on term pregnant women with Singleton living fetus attending Ain Shams University
Maternity Hospital for induction of labor with the following criteria:
Inclusion criteria:
1. women age: from 18 to 35 years old.
2. Single living term fetus with gestational age ≥ 37 weeks. 3- Eligible for IOL. 4- Bishop
score <6 5- Estimated fetal weight < 4Kg.
Exclusion criteria:
1. previous caesarean section. (increases risk of rupture uterus)
2. Multiple pregnancy, IUFD, preterm or macrosomic fetus (defined as fetus >4.5kg or fetus
of diabetic mother >4Kg) (increases risk of shoulder dystocia)
3. Women with major uterine anomalies. (appendix A: ESHRE/ESGE classification for Female
genital tract anomalies (Grimbizis GF, et al,. 2013) (increases risk of CS)
4. Vasa previa, placenta previa (increases risk of antepartum hemorrhage)
5. previous myomectomy reaching the endometrial cavity. (Increases risk of rupture uterus)
7- patient refuse to participate or inability to consent. (patient's right to refuse).
Sample Size and sample Size Justification:
Using the PASS 15 program for sample size calculation, reviewing results from a previous
study (Volpe et al.2022) showed that the cervical sliding sign (CSS) was found in 48% of the
study group (non-consecutive series of uncomplicated singleton term pregnancies, planned for
IOL, with a fetus in cephalic presentation patients), based on this frequency and after 20%
adjustment for dropout rate, a sample size of at least 130 participants produces a two-sided
95% confidence interval with a width equal to 0.199 when the sample proportion is 0.480.
Ethical Consideration:
This study will be done after approval of the ethical committee of the department of
obstetrics and gynecology, faculty of medicine, Ain Shams University. Informed consent will
be taken from all participants before recruitment in the study, and after explaining the
purpose and procedures of the study. The investigator will obtain the written, signed
informed consent of each subject prior to performing any study specific procedures on the
subject. The investigator will retain the original signed informed consent form. All
laboratory specimens, evaluation forms, reports, video recordings and other records that
leave the site will not include unique personal to maintain subject confidentiality. The
study will be based on the investigator self-funding.
Study procedures and interventions:
Women fitting into our inclusion criteria will be subjected to:
1. history taking (personal, obstetric, medical and surgical)
2. Transvaginal ultrasound to assess the presence of CSS with a semi-filled bladder using a
10 MHz endo-vaginal probe EC3-10T of Alpinion E-CUBE 5 ultrasound machine (ALPINION
MEDICAL SYSTEMS Co., Ltd. Guro-gu, Seoul, 08393, Republic of Korea) will be done by the
most senior resident. "The CSS will be evaluated as follows:
1- acquisition of a sagittal view of the cervix, on which the internal and external os and
the endocervical canal could be identified. 2- Gentle pressure with the transvaginal probe on
the cervix until maximum compression of the cervix is achieved. 3- Visualization of the
anterior cervical lip "sliding" on the posterior one is defined as the presence of CSS."
(Volpe, et al., 2022) 3- Induction and management of labor will be conducted following the
hospital's protocol (APPENDEX B: FIGO MISOPROSTOL-ONLY RECOMMENDED REGIMENS 2017(Morris JL,
et al., 2017)) 4- record the mode of delivery for each participant either vaginal delivery or
cesarean deliveries. 5- Measurement of induction-to-active-labor1 time (active labor time
defined as ≥ 6cm dilated cervix), active-labor-to-delivery time, total length of labor.
Outcomes:
- 1ry outcome: successful vaginal delivery.
- 2ry outcomes:
- induction-to-active-labor time interval.
- Active -labor-to-delivery time interval.
- Mode of Delivery (vaginal/ Instrumental/ Cesarean)
- Reason for CS (Fetal distress/ failure of induction/ failure of progress).
Statistical analysis:
- All data will be collected, tabulated, and statistically analyzed by software package
program
