NCT02337881

Brief Summary

The aim of this study is to assess whether or not the emergency tocolytic effect of combined nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms of inhibiting eminent preterm labor and improving perinatal outcomes.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
227

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

December 30, 2014

Last Update Submit

June 21, 2016

Conditions

Labor Preterm Requiring Hospitalization

Outcome Measures

Primary Outcomes (1)

  • the proportion of women remaining undelivered during the whole period of hospitalization. Treatment failure is considered in participants who delivered during this period, or those who need repeated treatment course.

    9 months

Secondary Outcomes (4)

  • readmission after discharge

    9 months

  • time (days) till delivery

    9 months

  • maternal outcomes (gestational age at delivery, mode of delivery, any complications during delivery)

    9 months

  • neonatal outcomes (weight, Apgar score, admission to neonatal intensive care unit

    9 months

Study Arms (2)

nifedipen and sildenafil

ACTIVE COMPARATOR

The protocol for nifedipen in our units consists of 20 mg orally stat, followed by 10 mg orally every 6-8 hours, at the same time sildenafil citrate will be administered vaginally in a dose of 25mg at 8 hourly intervals and both medications will be continued for 48-72 hours as indicated.

Drug: nifedipenDrug: Sildenafil

nifedipen only

ACTIVE COMPARATOR

nifedipine alone in the same regimen and duration described before.

Drug: nifedipen

Interventions

nifedipenDRUG

The protocol for nifedipen in our units consists of 20 mg orally stat, followed by 10 mg orally every 6-8 hours for 48 to 72 hours as needed

Also known as: inhibiting acute preterm labor
nifedipen and sildenafilnifedipen only
SildenafilDRUG

sildenafil citrate will be administered vaginally in a dose of 25mg at 8 hourly intervals and both medications will be continued for 48-72 hours as indicated.

Also known as: inhibiting acute preterm labor
nifedipen and sildenafil

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant patients presented in outpatient clinic, admitted through emergency room or referred from any other hospitals will be the candidates for the study if they are of any age, any parity, carrying a singleton pregnancy, at a gestational age (GA) between 24 and 34 weeks, and whether or not they had a previous history of PTL.

You may not qualify if:

  • The presence of major fetal anomaly, intrauterine fetal death, advanced cervical dilatation (\>4cm), membranes bulging into the vagina in asymptomatic women, history of ruptured membranes, major antepartum hemorrhage, major chronic medical disorder (such as chronic hypertension, chronic renal disease, and pre-gestational diabetes mellitus as these conditions would increase the risk of PTL and potentially confound the primary study outcome), twins or higher order multiple pregnancy, any other condition in which continuation of the pregnancy can harm the mother or fetus and any contraindication for nifedipin and/or nicorandil therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Menoufia University

Shebin Elkom, Egypt

RECRUITING

Alhayah national hospital

Abhā, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • menoufia university

    menoufia fuculty of medicine

    STUDY CHAIR

  • Alhayah national hospital

    Alhayah national hospital

    STUDY CHAIR

Central Study Contacts

mohamed maher

CONTACT

+966558198655mohamaher2015@gmail.com

tarek sayyed

CONTACT

00201222739097tareksayed70@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

SA(1)EG(1)