Effectiveness of Evening Primrose Oil for Induction of Labor

NCT ID: NCT06539975

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-10-12

Brief Summary

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Effectivness of primrose oil in induction of labour .

Detailed Description

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Using primrose oil in addition to misoprostol for induction of labor in one group of pregnant women and compare the result with those of another group in which we are using misoprstol only.

Conditions

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Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a douple-centered, serially-numbered closed opaque envelope, randomised clinical trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
Allocation concealment is the use of sequentially numbered,opaque,sealed envelopes.

Study Groups

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Evening primrose oil + misoprostol

combination of both drugs for induction of labor adminstrated vaginally.

Group Type ACTIVE_COMPARATOR

Evening Primrose Oil 1000 MG

Intervention Type DRUG

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

misoprostol only

misoprostol alone for induction of labor adminstrated vaginally.

Group Type OTHER

Evening Primrose Oil 1000 MG

Intervention Type DRUG

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

Interventions

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Evening Primrose Oil 1000 MG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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sayed mohamed sayed mostafa

sayed mohamed sayed mostafa

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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sayed mohamed, resident

Role: CONTACT

01093622038

Abdelrhaman abdelkader, DR

Role: CONTACT

01094628728

References

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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.

Reference Type BACKGROUND
PMID: 34261202 (View on PubMed)

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.

Reference Type RESULT
PMID: 33913585 (View on PubMed)

Other Identifiers

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primrose oil in labor

Identifier Type: -

Identifier Source: org_study_id

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