Effectiveness of Evening Primrose Oil for Induction of Labor

NCT06539975 | Not Yet Recruiting Early Phase 1

• 1 other identifier: primrose oil in labor
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effectivness of primrose oil in induction of labour .

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• The interval between induction of labor and delivery

  comparing between the interval between induction of labor and delivery in two groups one is using evening primrose oil + misoprostol and the other using misoprostol only.

  induction of labor may take more than 24 hours

Study Arms (2)

Evening primrose oil + misoprostol

ACTIVE COMPARATOR

combination of both drugs for induction of labor adminstrated vaginally.

Drug: Evening Primrose Oil 1000 MG

misoprostol only

OTHER

misoprostol alone for induction of labor adminstrated vaginally.

Drug: Evening Primrose Oil 1000 MG

Interventions

Evening Primrose Oil 1000 MG DRUG

Evening primrose oil 1000mg vaginally plus misoprostal for induction of labor

Evening primrose oil + misoprostol; misoprostol only

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregenent of 38 weeks and longer
• singleton pregenency
• vertex presentation
• indication of labor induction
• bishop score \<6 and cervical dilation\<2 cm

You may not qualify if:

• women who delivered by classical cs or had a history of myomectomy , hysterscopic uterine surgery , or cervical surgery like conisation
• women with multiple gestation
• women with evidence of low implanted placenta by ultrasound
• women with contraindication to misoprostol or vaginal delivery

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Hemmatzadeh S, Mohammad Alizadeh Charandabi S, Veisy A, Mirghafourvand M. Evening primrose oil for cervical ripening in term pregnancies: a systematic review and meta-analysis. J Complement Integr Med. 2021 Jul 14;20(2):328-337. doi: 10.1515/jcim-2020-0314. eCollection 2023 Jun 1.

  PMID: 34261202 BACKGROUND

• Moradi M, Niazi A, Heydarian Miri H, Lopez V. The effect of evening primrose oil on labor induction and cervical ripening: A systematic review and meta-analysis. Phytother Res. 2021 Oct;35(10):5374-5383. doi: 10.1002/ptr.7147. Epub 2021 Apr 29.

  PMID: 33913585 RESULT

MeSH Terms

Interventions

evening primrose oil

Central Study Contacts

sayed mohamed, resident

CONTACT

01093622038; sayedmohmed19@yahoo.com

Abdelrhaman abdelkader, DR

CONTACT

01094628728; Abdelrhamam.abdelkader@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Allocation concealment is the use of sequentially numbered,opaque,sealed envelopes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sayed mohamed sayed mostafa

Model Details: The study will be a douple-centered, serially-numbered closed opaque envelope, randomised clinical trial.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: December 10, 2024
• Primary Completion: September 10, 2025
• Study Completion: October 12, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08