Routine Cervical Dilatation at the Non-labour Caesarean Section and Its Influence on Postoperative Pain

Routine Cervical Dilatation at the Non-labor Caesarean Section and Its Influence on Postoperative Pain: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Cervical dilation

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.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11231
    • Ahmed Samy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cervical dilation group; the surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal after extraction of placenta and membranes and will remove the outer gloves after digital dilatation of the cervix.	Procedure: Cervical dilation; manual dilatation of the cervix using surgeon's finger.
No Intervention: no cervical dilation group; No cervical dilation will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change of postoperative pain over time points mentioned in the time frame	will be assessed using Numerical Rating Scale which is a segmented numeric version of the visual analog scale (VAS) in which the patient selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").the numeric rating scale will be either administered verbally (therefore also by telephone) or graphically for self-completion.Scores range from 0-10 points, with higher scores indicating greater pain intensity.	8th, 24th, and 48th hours ,4th and 7th day after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puerperal Endometritis	body temperature higher than 38.5 Celsius degree with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination	48 hours after operation
puerperal fever	a persistent fever of at least 38 Celsius degree taken from the axillary region on two occasions more than 6 h apart after the first postpartum day and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere.	1st and 2nd day postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Routine cervical dilatation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No