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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cervical dilation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ahmed Samy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cervical dilation group

no cervical dilation group

Arm Description

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.

No cervical dilation will be done.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Puerperal Endometritis
body temperature higher than 38.5 Celsius degree with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination
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.

Full Information

First Posted
March 24, 2018
Last Updated
June 24, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03513237
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical dilation group
Arm Type
Experimental
Arm Description
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.
Arm Title
no cervical dilation group
Arm Type
No Intervention
Arm Description
No cervical dilation will be done.
Intervention Type
Procedure
Intervention Name(s)
Cervical dilation
Intervention Description
manual dilatation of the cervix using surgeon's finger.
Primary Outcome Measure Information:
Title
mean change of postoperative pain over time points mentioned in the time frame
Description
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.
Time Frame
8th, 24th, and 48th hours ,4th and 7th day after the operation
Secondary Outcome Measure Information:
Title
Puerperal Endometritis
Description
body temperature higher than 38.5 Celsius degree with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination
Time Frame
48 hours after operation
Title
puerperal fever
Description
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.
Time Frame
1st and 2nd day postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Samy
City
Giza
ZIP/Postal Code
11231
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31401929
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.
Results Reference
derived

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

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