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NCT Number: NCT03513237

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Samy

Giza, 11231, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical dilation

Procedure

manual dilatation of the cervix using surgeon's finger.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 1, 2018
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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