NCT05196841

Brief Summary

Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and duration? Methods: This study was planned as a a double blind randomized controlled experimental study. The study was conducted with 60 pregnant women who were randomized between February 2019 and November 2020 at a university and private hospital located in Anatolia, Turkey.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

November 27, 2021

Last Update Submit

November 13, 2023

Conditions

Labor PainLabor Long

Keywords

Labor painLabor durationMidwifeAnastatica Hierochuntica

Outcome Measures

Primary Outcomes (1)

  • Severity of labor pain

    The primary outcomes included the severity of labor pain that was measured by VAS

    12 hours

Secondary Outcomes (1)

  • Duration of the active phase of labor

    12 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

Anastatica Hierochuntica

Behavioral: Anastatica Hierochuntica

Control group

NO INTERVENTION

routine care

Interventions

Anastatica HierochunticaBEHAVIORAL

During the sampling process, the researcher inquired through women who apply for pregnancy follow-up and contacted the mothers who had some inclusion criteria. Also, the researcher outlined the research plan and objectives. The participants were assessed based on the eligibility criteria and, if they were eligible and willing to participate in the study.

Experimental group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a singleton pregnancy at 38-42 weeks,
  • Pregnant women who had spontaneous labor,
  • Pregnant women with a healthy fetus,
  • Pregnant women without any complications that may cause dystocia during labor,
  • Pregnant women who did not receive analgesia and anesthesia during the first phase of labor,
  • Planned vaginal delivery, pregnant women who volunteered to participate in the research

You may not qualify if:

  • pregnant women with high-risk pregnancies, Planned caesarean delivery, pregnant women with chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hediye KARAKOC, PhD

    Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2021

First Posted

January 19, 2022

Study Start

February 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 15, 2023

Record last verified: 2021-11

Locations

TU(1)