Plain English Summary
Background and study aims
Labour induction is the process or treatment that stimulates childbirth and delivery. It is a common procedure and remains an obstetric challenge. The outcome of induction of labour is very important in a setting where women are prone to chronic anaemia in pregnancy and the adverse effects of heavy blood loss following childbirth. The aim of this study is to compare the outcomes of two different methods of inducing labour that are currently being used in the hospital.
Who can participate?
Pregnant women undergoing induction of labour at the University of Calabar Teaching Hospital
What does the study involve?
Participants are randomly allocated into two groups to have labour induced with either the drug misoprostol or a catheter (tube) inserted into the cervix. Vaginal blood loss is collected using a plastic bag and perineal pad for up to 6 hours after the birth. The time between the start of the intervention and when the baby is delivered is also measured, the wellness of the baby is assessed at 1 minute and 5 minute after delivery, and the acidity of the baby's blood is measured at time of cord clamping.
What are the possible benefits and risks of participating?
Benefits of participation in this study include having all investigations done at no cost and all subsequent treatment (except for Caesarean deliveries) paid for by the researcher. The risks include a possible reaction to the medication being used, risk of infection with insertion of the catheter, and risk of operative vaginal or Caesarean delivery.
Where is the study run from?
University of Calabar Teaching Hospital (Nigeria)
When is the study starting and how long is it expected to run for?
May 2013 to June 2014
Who is funding the study?
University of Calabar Teaching Hospital (Nigeria)
Who is the main contact?
Dr Okon Asuquo Okon
konie9ja@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Okon Okon
ORCID ID
http://orcid.org/0000-0002-7918-3334
Contact details
Department of Obstetrics and Gynecology
University of Calabar
Calabar
Cross River State
540001
Nigeria
+234 (0)8035909334
konie9ja@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PACTR201702002017237
Study information
Scientific title
Postpartum vaginal blood loss following two different methods of cervical ripening: a randomised controlled trial
Acronym
Study hypothesis
Induction of labor is a common procedure, and it remains an obstetric challenge. The outcome of induction of labor and its various determinants are paramount in a setting where women are prone to chronic anemia in pregnancy and the adverse effects of heavy blood loss following child birth. The study was designed to determine the postpartum outcome of two different methods of cervical ripening for induction of labor which are currently being used in the hospital.
Ethics approval
Health Research and Ethics Committee of UCTH, 07/10/2013, ref: UCTH/HREC/33/104
Study design
Single-center randomised open-label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Induction of labor
Intervention
The different groups receive different interventions at the same time during study, and allocation to either intervention group was randomised. Allocation sequence was generated by simple randomization using a randomization table created by a computer software program. The allocation sequence/code was concealed from the person allocating the participants to the intervention arms using sealed opaque envelopes. Masking: open-label (masking was not used)
Control group: Foley catheter, single insertion into the intra-cervical extra-amniotic space and left in-situ until the catheter was spontaneously expelled, at less than but not greater than 12 hours duration
Experimental group: Vaginal misoprostol, 50 microgram inserted into the posterior vaginal fornix 6 hourly and stopped when the participant was having adequate uterine contractions or to a maximum of 4 doses under 24 hours
Once the fetal head had crowned, a plastic bag was placed under the patient to collect the blood and hind water following the delivery of the fetus and the placenta. It did not require sterilization and was used in the dorsal, lateral, or lithotomy positions. The bag was left in situ until the birth attendant was no longer concerned about blood loss, such as when a sanitary towel was applied to the vulva. Thereafter the collected blood was poured into a graduated measuring cup, promptly read and recorded. The sanitary towel was left in place to collect blood lost per vagina until 6 hours postpartum and then weighed to determine the amount of blood lost. For women undergoing caesarean section the use of suction tubes and bottles and weighing of the abdominal mops, gauze and swabs was used to determine the amount of blood lost.
Intervention type
Drug
Phase
Not Applicable
Drug names
Misoprostol
Primary outcome measure
Postpartum vaginal blood loss, measured by collecting blood using an under buttocks plastic collection bag and by perineal pad from the crowning of the fetal head (second stage of labor) up to 6 hours post delivery
Secondary outcome measures
1. Induction delivery interval, measured from the start of intervention to time of childbirth
2. Wellness of the baby, assessed using the Apgar score score at 1 minute and 5 minute post delivery
3. Neonatal cord blood pH at time of cord clamping following delivery of the baby
Overall trial start date
01/05/2013
Overall trial end date
14/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 37 completed weeks up to 41 completed weeks plus 3 days
2. Bishop score of <5
3. A live singleton fetus with cephalic presentation at term with intact membranes with no evidence of labor
4. No contraindications to a vaginal delivery
5. Up to the third parity
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. History of uterine scar
2. Twins
3. Breech presentation
4. Fetal anomalies
5. Antepartum hemorrhage
6. Polyhydramnios
7. Presence of uterine fibroids in pregnancy
8. Known allergy to prostaglandin preparations
9. Women with anemia (defined as hemoglobin level less than 10.5g/dl or a hematocrit of less than 31%)
10. History of bleeding disorders
11. Pelvic abnormalities/deformities
Recruitment start date
30/04/2014
Recruitment end date
01/05/2014
Locations
Countries of recruitment
Nigeria
Trial participating centre
University of Calabar Teaching Hospital
Unical Hotel road off Etagbo road
Calabar Municipality
540001
Nigeria
Sponsor information
Organisation
University of Calabar Teaching Hospital
Sponsor details
Department of Obstetrics and Gynecology
University of Calabar
Calabar
Cross River State
540001
Nigeria
+234 (0)87-232055, (0)87-238513, (0)87-232053
mmeremiku@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University of Calabar Teaching Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the findings online as an open access article, available to medical and paramedical personnel who may find themselves working in countries where patients who may have chronic anemia (such as sickle cell disease patients) go into labor unprepared and in whom even minor blood loss may have a significant impact on their hemo-dynamic system.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Okon Asuquo Okon (konie9ja@gmail.com). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared from 1 month following publication with no end date. Anyone who wishes to access the data for any purpose. To gain access,
data requestors may need to send a data access agreement. Informed consent was obtained from all participants and anonymity ensured using only the randomization numbers that they picked from the bag containing the randomly generated numbers to identify them on the data sheet.
Intention to publish date
26/10/2017
Participant level data
Available on request
Basic results (scientific)
Publication list