The Efficacy of Nifedipine in the Management of Preterm Labor (BOG/TH/PTL)

The Tocolytic Efficacy of Nifedipine in the Management of Threatened and Advanced Preterm Labor: A Study on 444 Singleton Pregnant Women With Intact Membranes

Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. The correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. Nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. In the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.

Study Overview

Detailed Description

Preterm birth is the main reason of perinatal morbidity and mortality. The main management method of this important problem is to prolong the pregnancy period and to use corticosteroids to prevent fetal pulmonary distress. The most widely studied tocolytic agents, ritodrin, salbutamol and terbutaline are all betamimetics, and they are shown to prolong birth labor till 7 days and do not have any effct on the fetal mortality. However, their maternal side-effects are inevitable and can be mortal. They cause tachycardia, hypotension and some biochemical disturbances. Furthermore, maternal death is possible due to pulmonary edema. These adrenergic agonists are the first line tocolytics, but calcium canal blockers are becoming more popular since they have less side effects and comparable efficacy.

Calcium canal blockers are nonspecific smooth muscle relaxants used in adult hypertension treatment. Their tocolytic effect depends on their inhibition of calcium ions into the myometrial cells. In vitro studies have shown that they have strong relaxant effects on human myometrium. In the present study, our aim is to investigate the effects of nifedipine in our clinic in a period between 2002 and 2005, when it was first used in our clinic as the sıngle tocolytic agent. Its success in preventing preterm labor and its complications in our earlier practice will be noted and this retrospective study will guide us in its current usage, dosages and side-effects.

Study Type

Observational

Enrollment (Anticipated)

444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aysun Firat, M.D., Specialist of Obstetrics&Gynecology
  • Phone Number: +90 (532) 5462332
  • Email: aysunfirat@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Only pregnant women (23-37 weeks) with preterm labor

Description

Inclusion Criteria:

  • ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks.

Exclusion Criteria:

  • Normal pregnant women
  • Pregnent women before 23 weeks of gestation
  • Pregant women between 23 and 37 weeks of gestation, but with preterm early membrane rupture, chorioamnionitis, preterm labor without cervical change, multiple pregnancy, hypertension, intrauterine growth retardation, fetal anomaly, oligoanhidramniosis, placenta previa, decolman placentaand intrauterine fetal death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A - Advanced Preterm Labor (aPL)
Singleton pregnant women with spontaneous preterm labor at their 23-36 weeks: regular contractions 4 or more in 20 minutes and cervical dilatation at 2 cm and above
For both groups, when preterm labor is diagnosed, 10 mg capsule will be given sublinguially and if it is not effective in 1 hour, the same dose will be repeated again, and the same regimen will be repeated every day till preterm labor ends or proceed to a preterm birth.
Group B - Threatened Preterm Labor (tPL)
Singleton pregnant women with spontaneous preterm labor at their 23-36 weeks: regular contractions less then 4 in 20 minutes and cervical dilatation less then 2 cm
For both groups, when preterm labor is diagnosed, 10 mg capsule will be given sublinguially and if it is not effective in 1 hour, the same dose will be repeated again, and the same regimen will be repeated every day till preterm labor ends or proceed to a preterm birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay Delivery for 1 day
Time Frame: 1 day
After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours
1 day
Delay Delivery for 2 days
Time Frame: 2 days
After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours
2 days
Delay Delivery for 3 days
Time Frame: 3 days
After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours
3 days
Delay Delivery for 7 days
Time Frame: 7 days
After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours
7 days
Birth before 34 weeks
Time Frame: till 34 weeks of gestation
After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks
till 34 weeks of gestation
Birth before 37 weeks
Time Frame: till 37 weeks of gestation
After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks
till 37 weeks of gestation
Birth after 37weeks
Time Frame: after 37 weeks of gestation-normal birth
After start of tocolytic nifedipine, the preterm birth occurs after 37 weeks (Normal birth)
after 37 weeks of gestation-normal birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir, Study Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 15, 2020

Primary Completion (ANTICIPATED)

December 20, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (ACTUAL)

November 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available at Excel file and be shared by email upon any request.

IPD Sharing Time Frame

Data will become available on December 2020 and will be shared to the end of 2021.

IPD Sharing Access Criteria

Anyone who wants to see the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Birth

Clinical Trials on Nifedipine 10 mg

3
Subscribe