RBR-39rmvb Labour induction of patients with waters break and unfavorable cervix: oxytocin versus misoprostol

Date of registration: 11/03/2020 ^(mm/dd/yyyy)
Last approval date : 11/03/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1255-9812

• Public title:

  en

  Labour induction of patients with waters break and unfavorable cervix: oxytocin versus misoprostol

  pt-br

  Indução do parto em bolsa rota com colo desfavorável: ocitocina versus misoprostol

• Scientific acronym:

  pt-br

  ERAPT

• Public acronym:

  pt-br

  ERAPT

• Secondaries identifiers:
  • 27460619.5.0000.5327
    Issuing authority: Plataforma Brasil
  • 3.824.436
    Issuing authority: Comite de Ética do Hospital de Clinicas de Porto Alegre

Sponsors

• Primary sponsor: Hospital de Clinicas de Porto Alegre
• Secondary sponsor:
  • Institution: Hospital de Clinicas de Porto Alegre
• Supporting source:
  • Institution: Hospital de Clinicas de Porto Alegre

Health conditions

• Health conditions:

  en

  Premature Rupture of Fetal Membranes

  pt-br

  Ruptura Prematura de Membranas Fetais

• General descriptors for health conditions:

  en

  O00-O99 XV - Pregnancy, childbirth and the puerperium

  pt-br

  O00-O99 XV - Gravidez, parto e puerpério

• Specific descriptors:

Interventions

• Interventions:

  en

  Patients will be randomized into two groups: Group 1: 120 patients. Oxytocin at low doses of 2 mIU / min with an increase of 2 mIU / min every 20-30 minutes. Maximum dose 40 mIU / ml. Group 2: 120 patients. Misoprostol at dose 25 mcg, bucal administered every 4 hours.

  pt-br

  As pacientes serão randomizadas em dois grupos: Grupo 1: 120 pacientes. Ocitocina em baixas doses de 2 mUI/min com incremento de 2 mUI/min a cada 20-30 minutos. Dose máxima 40 mUI/ml. Grupo 2: 120 pacientes. Misoprostol na dose 25 mcg, via bucal (bochecha) a cada 4 horas.

• Descriptors:

  en

  O42.9 Premature rupture of membranes, unspecified

  pt-br

  O42.9 Ruptura prematura de membranas, não especificada

  es

  O42.9 Ruptura prematura de las membranas, sin otra especificación

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 03/01/2020 ^(mm/dd/yyyy)
• Date last enrollment: 09/01/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  240	F	18 Y	0 -

• Inclusion criteria:

  en

  Pregnant women admitted to the maternity of the Hospital de Clínicas de Porto Alegre (HCPA) with PROM; absence of labor; indication of labor induction; unfavorable cervix (Bishop index <4); between 34 and 41 weeks of gestation.

  pt-br

  Gestantes que internarem no HCPA com RUPREME; sem trabalho de parto; indicação de interrupção da gestação; colo com índice de Bishop igual ou menor que quatro; entre 34 e 41 semanas de gestação.

• Exclusion criteria:

  en

  Multiple gestation; previous cesarean sections; previous transmural myomectomy; non-reassuring fetal status; more than 3 contractions in 10 minutes; placenta previa or vasa previa; umbilical cord prolapse; abnormal presentations (pelvic or transverse); active herpes infection; invasive carcinoma of the uterine cervix; having denied labor induction.

  pt-br

  Gestação múltipla; Uma ou mais cesáreas prévias; Miomectomia transmural prévia; Avaliação fetal não tranquilizadora; Mais de 3 contrações em 10 minutos; Placenta prévia ou vasa prévia; Prolapso de cordão umbilical ou este precedendo a apresentação; Apresentação anômala (feto pélvico ou transverso); Infeção por herpes ativa; Carcinoma invasor do colo uterino; Tenha se negado a induzir o trabalho de parto

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	4

Outcomes

• Primary outcomes:

  en

  The aim of this study is demonstrate that the use of misoprostol to cervical ripening, in cases of RUPREME and unfavorable cervix, decreases the induction time until the beginning of the active phase of labor, increasing the chance of vaginal delivery.

  pt-br

  O objetivo primário é demonstrar que o uso de misoprostol para amadurecimento do colo nos casos de RUPREME e colo desfavorável diminui o tempo de indução até o início da fase ativa do trabalho de parto, aumentando a chance de parto vaginal.

• Secondary outcomes:

  en

  Secondary outcomes will be the mean time between the start of induction and delivery, side effects of both drugs and fetal outcomes.

  pt-br

  Objetivos secundários são calcular tempo total do início da indução e o parto; efeitos colaterais de ambas as drogas e desfechos fetais.

Contacts

• Public contact
  • Full name: Fernanda Oliveira Castilhos
  • • Address:
    • City: Porto Alegre / Brazil
    • Zip code: 90035-903
  • Phone: +55-54-981117015
  • Email: fernandacastilhos@icloud.com
  • Affiliation: Hospital de Clinicas de Porto Alegre
   
• Scientific contact
  • Full name: Fernanda Oliveira Castilhos
  • • Address:
    • City: Porto Alegre / Brazil
    • Zip code: 90035-903
  • Phone: +55-54-981117015
  • Email: fernandacastilhos@icloud.com
  • Affiliation: Hospital de Clinicas de Porto Alegre
   
• Site contact
  • Full name: Fernanda Oliveira Castilhos
  • • Address:
    • City: Porto Alegre / Brazil
    • Zip code: 90035-903
  • Phone: +55-54-981117015
  • Email: fernandacastilhos@icloud.com
  • Affiliation: Hospital de Clinicas de Porto Alegre
   

Additional links:

• Download in ICTRP format