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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Post Operative Pain

Treatments

Procedure: Cervical dilation

Study type

Interventional

Funder types

Other

Identifiers

NCT03513237
Routine cervical dilatation

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,200 participants in 2 patient groups

Cervical dilation group
Experimental group
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.
Treatment:
Procedure: Cervical dilation
no cervical dilation group
No Intervention group
Description:
No cervical dilation will be done.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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