N-Acetyl Cysteine for Prevention of Preterm Birth

NCT00568113 | Completed Phase 4

• 1 other identifier: 1-Shahin
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The antioxidant effect of N-Acetyl cysteine can abort the inflammatory cascade responsible for initiation of preterm labour especially among patients with reccurent preterm birth and patients having bacterial vaginosis

Conditions

Preterm Labour

Keywords

preterm labour; n acetyl cysteine; bacterial vaginosis

Outcome Measures

Primary Outcomes (1)

• number of patients completing 36 weeks of pregnancy

  4-8 weeks

Secondary Outcomes (1)

• prolongation of gestational weeks

  1-12 weeks

Study Arms (2)

NAC group

EXPERIMENTAL

NAC given plus 17Oh progesterone caproate

Drug: acetylcysteine in arm 1

Progesterone group

ACTIVE COMPARATOR

17 OH progesterone caproate

Drug: acetylcysteine in arm 1

Interventions

acetylcysteine in arm 1 DRUG

Arm 2, control group: given hydroxyl progesterone caproate (150mgm) every 3 days starting from the 28th week of pregnancy till completed 36 weeks of gestation. Arm 1 patients were given hydroxyl progesterone caproate (150mgm) weekly injections plus NAC 0.6 gm (Sedico, Egypt) orally daily starting from the 28th week of pregnancy till delivery or completed 36th week of pregnancy.

NAC group; Progesterone group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with previous preterm labour who attended the antenatal care clinic at Assiut University Hospital were recruited and counseled about participating in the study.
• A written informed consent was taken.
• Patients had the right to refuse to participate and/or withdraw from the study at ay time without being denied their regular full clinical care.
• Personal information as well as data collected were subjected to confidentiality and were not made available to third party.

You may not qualify if:

• Patients were excluded if they refused to participate in the study, had prelabour premature rupture of membranes (PPROM), had an incompetent cervical os proved by funneling of the internal os on ultrasound examination or by a documented history with or without a cercelage done in the previous or current pregnancy.
• Patients with twin pregnancy, intrauterine foetal death, malpresentations, known fetal anomaly, progesterone or heparin treatment during the current pregnancy, hypertension requiring medication, a seizure disorder, Irregular and/or unsure menstrual dates or abortion within 3 months prior to the last menses were also excluded.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Youssif Shahin

Asyut, Asyut Governorate, 71116, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Vaginosis, Bacterial

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ahmed Y Shahin, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: July 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 5, 2007

Record last verified: 2007-12

Locations

EG (1)