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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513237
• Other study ID #: Routine cervical dilatation
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 30, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 ?rst 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Cervical dilation
manual dilatation of the cervix using surgeon's finger.

Locations

Country	Name	City	State
Egypt	Ahmed Samy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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 ?rst postpartum day and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere.	1st and 2nd day postoperative