NCT03693638

Brief Summary

The aim of this study was to compare haemodynamic changes, total dose of ephedrin requirement, and level of sensory blockade between fractionated dose and single dose spinal anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent Caesarean section

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

September 26, 2018

Last Update Submit

February 2, 2019

Conditions

Pregnancy Induced Hypertension

Keywords

spinal anesthesiapregnancy-induced hypertensionCesarean section

Outcome Measures

Primary Outcomes (1)

  • Change of mean arterial pressure (MAP)

    drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary

    15 minutes

Study Arms (2)

Single dose (SD)

ACTIVE COMPARATOR

2,5 ml total anesthetic drug dose (Bupivacaine-fentanyl) were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds

Drug: Bupivacaine-fentanyl

Fractionated dose (FD)

ACTIVE COMPARATOR

1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given

Drug: Bupivacaine-fentanyl

Interventions

Bupivacaine-fentanylDRUG

2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds

Single dose (SD)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • with hypertension in pregnancy (gestational hypertension or preeclampsia)
  • ASA II-III
  • aged 18 - 40 years
  • BMI 18.5 - 35 kg/m2
  • singleton pregnancy
  • would undergo spinal anesthesia for emergency or semi-emergency caesarean section

You may not qualify if:

  • chronic hypertension
  • eclampsia
  • pulmonary edema
  • cerebrovascular diseases
  • type-2 diabetes mellitus and gestational diabetes
  • placental abruption/previa/accreta
  • umbilical cord prolapse
  • gestational age \<34 weeks
  • estimated fetal weight \<=2.300 gram and \>=4.000 gram
  • polyhydramnios
  • fetal distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • Chumpathong S, Chinachoti T, Visalyaputra S, Himmunngan T. Incidence and risk factors of hypotension during spinal anesthesia for cesarean section at Siriraj Hospital. J Med Assoc Thai. 2006 Aug;89(8):1127-32.

    PMID: 17048420BACKGROUND

  • Sharwood-Smith G, Drummond GB. Hypotension in obstetric spinal anaesthesia: a lesson from pre-eclampsia. Br J Anaesth. 2009 Mar;102(3):291-4. doi: 10.1093/bja/aep003. No abstract available.

    PMID: 19218369BACKGROUND

  • Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth. 2017 Jan;61(1):55-60. doi: 10.4103/0019-5049.198390.

    PMID: 28216705BACKGROUND

  • Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.

    PMID: 15220175BACKGROUND

  • Nugroho AM, Sugiarto A, Chandra S, Lembahmanah L, Septica RI, Yuneva A. A Comparative Study of Fractionated Versus Single Dose Injection for Spinal Anesthesia During Cesarean Section in Patients with Pregnancy-Induced Hypertension. Anesth Pain Med. 2019 Feb 6;9(1):e85115. doi: 10.5812/aapm-85115. eCollection 2019 Feb.

    PMID: 30881909DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 3, 2018

Study Start

January 1, 2018

Primary Completion

April 30, 2018

Study Completion

May 31, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

ID(1)