The Efficacy of Nifedipine in the Management of Preterm Labor

NCT04644354 | Unknown

• 1 other identifier: BakirkoyDogumeviTez/2005
• Study Type: observational
• Target: 444
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preterm Labor; Preterm Birth; Preterm Labor Without Delivery; Preterm Labor With Preterm Delivery in Third Trimester; Calcium-Channel Blockers Toxicity; Side Effect of Drug

Keywords

Nifedipine; Tocolytics

Outcome Measures

Primary Outcomes (7)

• Delay Delivery for 1 day

  After start of tocolytic nifedipine, the delay recorded till delivery is only 24 hours

  1 day

• Delay Delivery for 2 days

  After start of tocolytic nifedipine, the delay recorded till delivery is 48 hours

  2 days

• Delay Delivery for 3 days

  After start of tocolytic nifedipine, the delay recorded till delivery is 72 hours

  3 days

• Delay Delivery for 7 days

  After start of tocolytic nifedipine, the delay recorded till delivery is 168 hours

  7 days

• Birth before 34 weeks

  After start of tocolytic nifedipine, the preterm birth occurs before 34 weeks

  till 34 weeks of gestation

• Birth before 37 weeks

  After start of tocolytic nifedipine, the preterm birth occurs before 37 weeks

  till 37 weeks of gestation

• Birth after 37weeks

  After start of tocolytic nifedipine, the preterm birth occurs after 37 weeks (Normal birth)

  after 37 weeks of gestation-normal birth

Study Arms (2)

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

Drug: Nifedipine 10 mg

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

Drug: Nifedipine 10 mg

Interventions

Nifedipine 10 mg DRUG

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 A - Advanced Preterm Labor (aPL); Group B - Threatened Preterm Labor (tPL)

Eligibility Criteria

• Gender Eligibility Details: Only singleton pregnent women with preterm labor. All are between 23 and 37 weeks of gestation with intact membranes.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic: lead

Related Publications (3)

• Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.

  PMID: 24901312 BACKGROUND

• de Heus R, Mulder EJ, Visser GH. Management of preterm labor: atosiban or nifedipine? Int J Womens Health. 2010 Aug 9;2:137-42. doi: 10.2147/ijwh.s7219.

  PMID: 21072306 BACKGROUND

• Smith GN. What are the realistic expectations of tocolytics? BJOG. 2003 Apr;110 Suppl 20:103-6. doi: 10.1016/s1470-0328(03)00053-3.

  PMID: 12763123 BACKGROUND

Related Links

• Principal sponsor ID

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aysun Firat, M.D., Specialist of Obstetrics&Gynecology, Dir

  Study Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysun Firat, M.D., Specialist of Obstetrics&Gynecology

CONTACT

+90 (532) 5462332; aysunfirat@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: December 15, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 30, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available on December 2020 and will be shared to the end of 2021.
• Access Criteria: Anyone who wants to see the data.