Clinical trial NCT03513237: Routine Cervical Dilatation at the Non-labour Caesarean Section and Its Influence on Postoperative Pain
Official title: Routine Cervical Dilatation at the Non-labor Caesarean Section and Its Influence on Postoperative Pain: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Caesarean section is a common method of delivery in obstetrics. With the recent increase in the rate of this procedure, it is wise to understand and implement the optimal surgical technique. Therefore, different operational methods have been defined to reduce the risk of peri/post-operative morbidity.

The digital dilatation of cervix during elective caesarean section has still been a concern when evaluating this issue. This procedure is supposed to help the drainage of blood and lochia postpartum, thus reducing infection or the risk of postpartum haemorrhage (PPH). However, on the contrary, this mechanical manipulation may also result in contamination by a vaginal micro-organism and increase the risk of infections or cervical trauma. Additionally, the effect of routine cervical dilatation on patients' perception of pain has not been studied sufficiently yet. As a result, the current literature lacks evidence of cervical dilatation on postoperative pain and is even not all in agreement regarding the potential benefits on overall maternal morbidity.

Detailed description: Caesarean section is a common method of delivery in obstetrics. With the recent increase in the rate of this procedure, it is wise to understand and implement the optimal surgical technique. Therefore, different operational methods have been defined to reduce the risk of peri/post-operative morbidity.

The digital dilatation of cervix during elective caesarean section has still been a concern when evaluating this issue. This procedure is supposed to help the drainage of blood and lochia postpartum, thus reducing infection or the risk of postpartum haemorrhage (PPH). However, on the contrary, this mechanical manipulation may also result in contamination by a vaginal micro-organism and increase the risk of infections or cervical trauma. Additionally, the effect of routine cervical dilatation on patients' perception of pain has not been studied sufficiently yet. As a result, the current literature lacks evidence of cervical dilatation on postoperative pain and is even not all in agreement regarding the potential benefits on overall maternal morbidity.

In this prospective study, our primary aim is to evaluate the effect of intra-operative digital dilatation of cervix on post-operative pain. We hypothesize that dilatation of the cervix as compared with non-dilatation will result in less pain by reducing fluid and blood stasis inside the uterine cavity. Our secondary objective is to assess the maternal morbidity including a reduction in haemoglobin concentrations, puerperal fever, puerperal endometritis and wound infection.

Eligibility criteria: Inclusion Criteria:

* Age: 18-40
* Gestational age: ≥ 37 weeks gestation with a BMI \> 25 kg/m².
* Singleton pregnancy.
* Free medical history.
* Nulliparous women who would undergo their ﬁrst elective cesarean section at term without any labor pain or multiparous women who had undergone cesarean section in all the previous pregnancies without any labor pain.)

Exclusion Criteria:

* the onset of labor with dilation of the cervix or women who felt labor pain before their previous cesarean operations.
* Prolonged premature rupture of membranes.
* Fever on admission or ongoing infection as Chorioamnionitis.
* Current antibiotic therapy.
* The need for Blood transfusion during or after CS.
* Emergency CS and preterm cesarean section.
* Pre-existing maternal disease as prepregnancy diabetes mellitus.
* Women at term who had risk factors for postpartum haemorrhage, e.g. placenta previa
* Women with Chronic pelvic pain

Primary outcomes:
measure: mean change of postoperative pain over time points mentioned in the time frame
timeFrame: 8th, 24th, and 48th hours ,4th and 7th day after the operation
Secondary outcomes:
measure: Puerperal Endometritis
timeFrame: 48 hours after operation
measure: puerperal fever
timeFrame: 1st and 2nd day postoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Samy
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alalfy M, Yehia A, Samy A. Routine cervical dilatation at caesarean section and its influence on postoperative pain and complications in obese women: a double blind randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1906-1913. doi: 10.1080/14767058.2019.1651274. Epub 2019 Aug 11.