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

NCT03513237 | Completed

• 1 other identifier: Routine cervical dilatation
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Puerperal Endometritis

  48 hours after operation

• puerperal fever

  1st and 2nd day postoperative

Study Arms (2)

Cervical dilation group

EXPERIMENTAL

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

no cervical dilation group

NO INTERVENTION

No cervical dilation will be done.

Interventions

Cervical dilation PROCEDURE

manual dilatation of the cervix using surgeon's finger.

Cervical dilation group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Samy

Giza, 11231, Egypt

Location

Related Publications (1)

• 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.

  PMID: 31401929 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Labor Stage, First

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Labor Onset; Labor, Obstetric; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The women will be blinded to the intervention, but the investigator will not be blinded to the procedure allocation (due to the nature of the intervention).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: May 1, 2018
• Study Start: April 15, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 30, 2018
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

EG (1)