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Completed

NCT Number: NCT03980951

Neuroaxial Labour Analgesia

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal outcomes

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Key information

Conditions

Labor Analgesia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University, Cairo, Abbasyia, Egypt

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Nulliparous parturient
  • Singleton, vertex gestation at term (37-42 weeks)
  • Less than 5 cm dilation
  • request an epidural technique for labor analgesia

Exclusion criteria

  • Hypersensitivity to local the study drugs
  • Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  • Any contraindication to the administration of an epidural technique
  • Risk factor for cesarean delivery.
  • fetal anomalies

Treatment and study plan

Dural Puncture Epidural Technique

Procedure

three labor analgesia techniques

Combined Spinal Epidural without intrathecal opioids

Procedure

three labor analgesia techniques

Epidural

Procedure

three labor analgesia techniques

Primary outcomes

  1. epidural Local anesthetic consumption

    Time frame: 1 year

Secondary outcomes

  1. Maternal hypotension

    Time frame: 1 year

    maternal mean arterial blood pressure less than 50 mmhg

  2. incidence of fetal bradycardia

    Time frame: 1 year

    a fetal heart rate of less than 100 beats per minute

  3. incidence of maternal pruritus

    Time frame: 1 year

    Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe

  4. labour pain scores

    Time frame: 1 year

    Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)

Sponsors and collaborators

Lead sponsor

Wahba bakhet

Other

Collaborators

  • elite medical hospital

Registry information

Official study title

A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Mar 24, 2020

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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