Condition category
Pregnancy and Childbirth
Date applied
23/09/2017
Date assigned
16/10/2017
Last edited
16/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://ucth-ng.net/

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

Publication citations

Additional files

Editorial Notes