Phloroglucinol Effectiveness on Shortening the Duration o... | NCT07184099

Studies
Phloroglucinol Effectiveness on Shortening the Duration of Active Phase of Labor

NCT07184099

Sponsor

Muhammad Aamir Latif

Status

Completed

Last Update Posted

Sep 19, 2025Actual

Enrollment

134Actual

Phase

Not Applicable

Conditions

Labor

Interventions

Phloroglucinol

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Sep 13, 2025

First Submission Date that Met QC Criteria

Sep 18, 2025

First Posted Date

Sep 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2025

Last Update Posted Date

Sep 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was planned to fill the gaps regarding the effectiveness of phloroglucinol on the duration of active phase of labor.

Detailed Description

In today's era, the focus has shifted from a "wait and watch" policy to "active intervention sooner than later" to enhance better labor outcomes. Using an ideal antispasmodic drug would help achieve a rapid and prolonged effect on cervical dilation, with no adverse impact on uterine contractions or causing uterine inertia. If the current study finds phloroglucinol effective in shortening the duration of the active phase of labor, it would help achieve better patient outcomes.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phloroglucinol group	Experimental	Phloroglucinol was administered as intravenous stat infusion with Ringer Lactate infusion.	Drug: Phloroglucinol
Placebo group	No Intervention	The patients were given only Ringer Lactate infusion.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phloroglucinol	Drug	Phloroglucinol was administered as intravenous stat infusion with Ringer Lactate infusion.	Phloroglucinol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of labor	The duration of labor was measured from the time of diagnosis of labor until full dilatation of cervix.	4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women aged between 18-35 years
Period of gestation above 37 weeks.

Exclusion Criteria:

Women with cephalopelvic disproportion
Double scare uterus
Fetal distress
Life threatening bleeding
Eclampsia
History of heart disease
Known allergy to phloroglucinol

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tahira Riaz, FCPS	Combined military hospital Attock	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Combined Military Hospital		Attock	Punjab Province	43100	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Data can be shared on a reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010696	Phloroglucinol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided