Oral Cleft Prevention Trial in Brazil

Status Completed

Clinical Trial Summary

Cleft lip and palate are a significant component of morbid human birth defects in the developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus 0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.

Clinical Trial Description

Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the impact of birth defects on fetal and neonatal health directly and maternal health indirectly. Craniofacial anomalies comprise a significant component of morbid human birth defects. The primary hypothesis is that folic acid supplementation of 4mg/day at preconception and during the first three months of pregnancy will decrease the recurrence of nonsyndromic cleft lip with or without clef palate (NSCL/P) in a high-risk group of women when compared to women taking 0.4 mg per day of folic acid. The total sample will include 2,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg versus the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects as well as the two study groups (4mg, 0.4 mg) to that of a historical control group.

The primary outcome assessed is the rate of recurrences of NSCL/P in offspring of the trial mothers in each of the two study groups. Secondary outcomes include recurrence of NSCL/P compared to a historical control group; serum and red cell folate levels; severity of NSCL/P in offspring of trial mothers; twinning rate; miscarriage rate; preeclampsia; rates of other birth defects; birth weight; and gestational age. The sample size was based on historic tables of birth rates and the rates of cleft occurrences. The study hypothesizes that a total of 2000 subjects will be enrolled during a 2.5 year period; a dropout rate of 10%; birth rate for group A (women with NSCL/P) of 10% and a rate of 12% for group B (women with at least one child with NSCL/P); risk of cleft for group A is 7% and for group B is 4%; one-sided test with continuity correction. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00098319
Study type	Interventional
Source	NICHD Global Network for Women's and Children's Health
Contact
Status	Completed
Phase	Phase 3
Start date	January 2004
Completion date	April 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00340977` - Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)
Completed	`NCT05166408` - Fistiulation Rate Following Primary Cleft Repair≤	N/A
Recruiting	`NCT03839290` - Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
Recruiting	`NCT01867632` - Acellular Dermal Matrix in Primary Furlow Palatoplasty	N/A
Completed	`NCT02900014` - Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate	N/A
Withdrawn	`NCT02953145` - The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery	Phase 4
Completed	`NCT04725370` - Characterization of Cleft Lip and Palate Conditions in Guatemala
Withdrawn	`NCT03572907` - Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.
Enrolling by invitation	`NCT02702869` - Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Completed	`NCT02583100` - Improving Outcomes in Cleft Palate Surgery	N/A
Recruiting	`NCT06072495` - Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI	N/A
Completed	`NCT04718558` - Optic Nerve Sheath Diameter Measurement in Cleft Palate Repair
Not yet recruiting	`NCT05357092` - Effects of AlignBabyCleft (ABaCleft)	N/A
Completed	`NCT01500109` - Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair	N/A
Completed	`NCT01252264` - FaceBase Biorepository
Completed	`NCT00397917` - Oral Cleft Prevention Program	Phase 3
Enrolling by invitation	`NCT03632044` - Evaluation of Trigeminal Nerve Blockade	Phase 4
Completed	`NCT04277273` - Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris	N/A
Completed	`NCT05405738` - Cleft Palate Technique and Maxillary Growth
Completed	`NCT03170505` - Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.