NCT02862925

Brief Summary

This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the intermittent auscultation protocols at KCMC, and to validate whether or not a handheld Doppler device can perform the fetal scalp stimulation test accurately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

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

First Submitted

Initial submission to the registry

August 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 5, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

August 2, 2016

Last Update Submit

September 1, 2017

Conditions

Fetal DistressStillbirthBirth AsphyxiaAcidosis

Keywords

fetal monitoringcesarean deliveryobstetricsmidwiferydeveloping countries

Outcome Measures

Primary Outcomes (2)

  • Feasibility as measured by completion of all 3 study objectives

    Day 1

  • Predicted fetal acidosis from cord blood pH (at thresholds of cord blood pH<7.0, 7.1, and 7.2)

    The primary outcome is the sensitivity and specificity of the Doppler device to predict fetal acidosis based on the fetal scalp stimulation test.

    Day 1

Secondary Outcomes (2)

  • Fetal distress rate

    Day 1

  • Change in cesarean delivery rate

    baseline, post introduction of fetal scalp stimulation (during labour)

Other Outcomes (2)

  • Birth asphyxia/stillbirth rate

    Day 1

  • NICU Admission Rate

    Day 1

Study Arms (2)

Pre-Intervention

NO INTERVENTION

A consecutive sample of 350 patients will be collected. After informed consent, data will be abstracted from the patient's record including day and time of delivery, method of delivery, parity, gestational age, meconium presence, heart rate abnormality and induction methods. For CD, the following data will be collected: decision-to-delivery time, Partogram adherence, time of each FSST, Apgar score, date and time of delivery and Comorbidities such as: Hypertension-spectrum disorders, Malaria, Postpartum Hemorrhage, Macrosomia, History of CD, Diabetes, Sickle Cell, and HIV status.

Post-intervention

EXPERIMENTAL

The study will take place on the labor ward at KCMC in Moshi, Tanzania. It will involve women who present to the labor ward in labor or who undergo an induction of labor. A consecutive sample of 350 patients will be collected. Study investigators will be present for 24 hours a day, 7 days a week on a rotating schedule during the enrollment period. All patients who fit inclusion and exclusion criteria will be approached if they are deemed medically stable.

Procedure: Fetal Scalp Stimulation

Interventions

Fetal Scalp StimulationPROCEDURE

During a routine vaginal exam, if there is concern for fetal distress based on local definitions, the midwife will gently stroke the fetal head with her finger. She will then observe for a rise in the fetal heart rate as observed by the Doppler monitor. A rise to above 15 beats per minute above the baseline is termed an "acceleration" and NEGATIVE test. Absence of an acceleration is a POSITIVE test and reason for intervention.

Post-intervention

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Gestational Age ≥ 37 weeks
  • Singleton gestation
  • Cephalic presentation
  • First stage of labor
  • Fetal distress diagnosed in the labor ward by either FHR \>160 or \<110, and/or grade 2-3 meconium-stained liquor

You may not qualify if:

  • Chorioamnionitis
  • Known fetal anomaly
  • Antepartum hemorrhage
  • Eclampsia
  • Other maternal/fetal factors precluding vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Christian Medical Center

Moshi, Kilimanjaro, Tanzania

Location

Related Publications (7)

  • Visser GH, Ayres-de-Campos D; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Adjunctive technologies. Int J Gynaecol Obstet. 2015 Oct;131(1):25-9. doi: 10.1016/j.ijgo.2015.06.021. No abstract available.

    PMID: 26433402BACKGROUND

  • Omo-Aghoja L. Maternal and fetal Acid-base chemistry: a major determinant of perinatal outcome. Ann Med Health Sci Res. 2014 Jan;4(1):8-17. doi: 10.4103/2141-9248.126602.

    PMID: 24669324BACKGROUND

  • Clark SL, Gimovsky ML, Miller FC. The scalp stimulation test: a clinical alternative to fetal scalp blood sampling. Am J Obstet Gynecol. 1984 Feb 1;148(3):274-7. doi: 10.1016/s0002-9378(84)80067-8.

    PMID: 6695974BACKGROUND

  • Clark SL, Gimovsky ML, Miller FC. Fetal heart rate response to scalp blood sampling. Am J Obstet Gynecol. 1982 Nov 15;144(6):706-8. doi: 10.1016/0002-9378(82)90441-0.

    PMID: 7137256BACKGROUND

  • Skupski DW, Rosenberg CR, Eglinton GS. Intrapartum fetal stimulation tests: a meta-analysis. Obstet Gynecol. 2002 Jan;99(1):129-34. doi: 10.1016/s0029-7844(01)01645-3.

    PMID: 11777523BACKGROUND

  • Rathore AM, Ramji S, Devi CB, Saini S, Manaktala U, Batra S. Fetal scalp stimulation test: an adjunct to intermittent auscultation in non-reassuring fetal status during labor. J Obstet Gynaecol Res. 2011 Jul;37(7):819-24. doi: 10.1111/j.1447-0756.2010.01442.x. Epub 2011 Mar 16.

    PMID: 21410829BACKGROUND

  • Goodman DM, Mlay P, Thielman N, Small MJ, Schmitt JW. Using fetal scalp stimulation with Doppler ultrasonography to enhance intermittent auscultation in low-resource settings: a diagnostic trial from Tanzania. BMC Pregnancy Childbirth. 2019 Feb 13;19(1):71. doi: 10.1186/s12884-019-2212-z.

    PMID: 30760224DERIVED

Related Links

MeSH Terms

Conditions

Fetal DistressStillbirthAsphyxia NeonatorumAcidosis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsFetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John Schmitt, MD

    Duke UMC, Duke Global Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 11, 2016

Study Start

October 1, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

September 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)