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Trial record 97 of 143 for:    NIFEDIPINE

Management of Acute Preterm Labor: Nifedipen Alone or Combined With Cildenafil Citrate

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ClinicalTrials.gov Identifier: NCT02337881
Recruitment Status : Unknown
Verified June 2016 by Al Hayat National Hospital.
Recruitment status was:  Recruiting
First Posted : January 14, 2015
Last Update Posted : June 22, 2016
Sponsor:
Collaborator:
Menoufia University
Information provided by (Responsible Party):
Al Hayat National Hospital

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.

Condition or disease Intervention/treatment Phase
Labor Preterm Requiring Hospitalization Drug: nifedipen Drug: Sildenafil Phase 1

Detailed Description:

Women will be randomly assigned into two study groups using a computerized random number table generator in order to get the trial sequence which will be hidden in sealed numbered opaque envelopes. Each envelope contains a single element (assignment) of the trial sequence. The statistician generated the random allocation sequence, and the investigators enrolled the participants.

Each patient will undergo an ultrasound examination prior to randomization to confirm GA, rule out major fetal anomalies and to determine cervical measurements. Dexamethasone in a total dose of 24 mg will be administered to all patients if not given in a previous admission.

Eligible women are then randomly assigned into two study groups:

Group I: (combined nifedipine and sildenafil citrate) 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.

Group II: (nifedipine alone) will receive therapy by nifedipine alone in the same regimen and duration described before.

During therapy, maternal (pulse rate, blood pressure, uterine contractions), as well as fetal (heart rate) monitoring will be performed every 15-30 minutes during the first 4 hours following the start of therapy then every 2 hours during the rest of treatment period. Patients whose contractions will stop after 48-72 hours will be observed for additional 24 hours to detect if contractions appear again so that if they remain stable, then they can be discharged and asked to come for follow-up after 1 week. As we stated in a previous work (13) that vaginal progesterone was effective for preventing recurrent PTL, thus all discharged patients will be advised to continue on progesterone till completed 36 weeks' gestation. In addition to progesterone treatment, all patients will be instructed to undergo periods of bed rest and, also they will be educated about the symptoms of PTL. The provided antenatal care will be at 2-weekly intervals till delivery. At any time if preterm contractions appeared re-admission with repeated treatment using the same drug will be used. At delivery, all data regarding the timing of labor onset, along with maternal and neonatal complications, will be documented.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Combined Nifedipine and Sildenafil Citrate Versus Nifedipine Alone in Acute Tocolysis of Preterm Labor: A Randomized Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

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Arm Intervention/treatment
Active Comparator: nifedipen and sildenafil
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: nifedipen
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
Other Name: inhibiting acute preterm labor

Drug: Sildenafil
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.
Other Name: inhibiting acute preterm labor

Active Comparator: nifedipen only
nifedipine alone in the same regimen and duration described before.
Drug: nifedipen
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
Other Name: inhibiting acute preterm labor




Primary Outcome Measures :
  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. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. readmission after discharge [ Time Frame: 9 months ]
  2. time (days) till delivery [ Time Frame: 9 months ]
  3. maternal outcomes (gestational age at delivery, mode of delivery, any complications during delivery) [ Time Frame: 9 months ]
  4. neonatal outcomes (weight, Apgar score, admission to neonatal intensive care unit [ Time Frame: 9 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337881


Contacts
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Contact: mohamed maher +966558198655 mohamaher2015@gmail.com
Contact: tarek sayyed 00201222739097 tareksayed70@yahoo.com

Locations
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Egypt
Menoufia University Recruiting
Shebin Elkom, Egypt
Principal Investigator: tarek sayed         
Saudi Arabia
Alhayah national hospital Recruiting
Abha, Saudi Arabia
Principal Investigator: mohamed maher         
Sponsors and Collaborators
Al Hayat National Hospital
Menoufia University
Investigators
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Study Chair: menoufia university menoufia fuculty of medicine
Study Chair: Alhayah national hospital Alhayah national hospital

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Responsible Party: Al Hayat National Hospital
ClinicalTrials.gov Identifier: NCT02337881     History of Changes
Other Study ID Numbers: ob/gyn 2
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Nifedipine
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sildenafil Citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents