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

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ClinicalTrials.gov Identifier: NCT03513237
Recruitment Status : Not yet recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

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.


Condition or disease Intervention/treatment Phase
Post Operative Pain Procedure: Cervical dilation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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).
Primary Purpose: Prevention
Official Title: Routine Cervical Dilatation at the Non-labor Caesarean Section and Its Influence on Postoperative Pain: A Randomised Controlled Trial
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. mean change of postoperative pain over time points mentioned in the time frame [ Time Frame: 8th, 24th, and 48th hours ,4th and 7th day after the operation ]
    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 :
  1. Puerperal Endometritis [ Time Frame: 48 hours after operation ]
    body temperature higher than 38.5 Celsius degree with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination

  2. puerperal fever [ Time Frame: 1st and 2nd day postoperative ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-40
  • Gestational age: more than 37 weeks gestation.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513237


Contacts
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Contact: AHMED SAMY, MD 01100681167 ahmedsamy8233@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AHMED SAMY, MD Cairo University

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Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03513237     History of Changes
Other Study ID Numbers: Routine cervical dilatation
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms